Plasma fibroblast pen
Also known as: plasma pen, plasma exeresis, fibroblast skin tightening
A plasma fibroblast pen uses a small electrical arc to produce a focused effect on skin. Particular devices are used for tissue removal or cosmetic skin tightening. The procedure creates an injury that heals afterwards; the device, treatment site and clinical assessment determine its appropriate use.
In plain English — This treatment uses focused electrical energy on the skin. Small studies of particular devices have reported improvements in upper-eyelid appearance. There is a healing period, so assessing the skin and planning aftercare are important parts of deciding whether treatment is suitable.
Evidence status
Emerging
Promising small clinical studies; device-specific evidence. Small human studies report improvements in upper-eyelid appearance after treatment with named plasma devices. Comparisons are limited, and documented complications require attention to selection, healing and periocular safety. Regulatory status must be checked for the actual device, purpose and jurisdiction.
What a plasma fibroblast pen is, and the types available#
An electrical-arc plasma device uses electrical energy to ionise the air near its tip and produce a focused effect on tissue. The names plasma pen, plasma exeresis and fibroblast skin tightening are used in cosmetic practice. The effect and intended use must be established from the specific device: FDA documentation for Plasma MD/Plasma + describes tissue removal and coagulation, while published Plexr research concerns upper-eyelid appearance.[1, 2]iElectrical-arc plasma devices ionise air and deliver focused energy that removes, coagulates or injures tissue; the fibroblast name does not describe injection of cells.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1
The word fibroblast refers to a proposed tissue-response rationale, not cells being injected. Health Canada describes the procedure’s focused energy as creating a controlled burn, after which healing occurs. That places assessment of the tissue and its likely recovery at the centre of the consultation.[1, 2]iElectrical-arc plasma devices ionise air and deliver focused energy that removes, coagulates or injures tissue; the fibroblast name does not describe injection of cells.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1
Devices studied under related names include Plexr, a direct plasma-jet system and an electrocarbonisation comparator. Their identities should stay attached to their results. The subject here is these aesthetic plasma-arc applications; a supplier’s exact technical description is more useful than the word plasma alone.[1, 2]iElectrical-arc plasma devices ionise air and deliver focused energy that removes, coagulates or injures tissue; the fibroblast name does not describe injection of cells.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1
Use of plasma fibroblast pens in aesthetic practice#
The documented uses include treatment of selected skin lesions within a named device’s indication and cosmetic treatment of eyelid skin laxity in clinical studies. Lesion diagnosis and assessment of eyelid function are clinical questions; a cosmetic request should not substitute for either.[10]iA lesion thought to be a skin tag may instead be another lesion, including skin cancer; appropriate diagnosis should precede destructive cosmetic treatment.Inferred from adjacent evidence[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
Device status
The FDA’s K223440 indication reads: “The Plasma MD or Plasma + is intended for the removal and destruction of skin lesions and coagulation of tissue.” The document identifies prescription use in the US. It concerns those devices and that indication, not every pen sold under a similar description, UK operator permission or a clearance specifically demonstrating an eyelift equivalent to surgery.[1]FDA K223440 clears the named prescription-use Plasma MD/Plasma + devices for removal/destruction of skin lesions and coagulation of tissue, not every plasma pen or a general claim of surgical-equivalent eyelid lifting.Directly tested by the source[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1
Health Canada’s advisory needs to be read with its 11 May 2022 update, which states that certain pens are authorised for healthcare professionals. Its older headline alone is not an adequate description of the updated Canadian position.[2]Health Canada's May 2022 update states that certain plasma pens are authorised for healthcare professionals; the old advisory headline alone gives an incomplete account of current wording.Directly tested by the source[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1
For the UK market, MHRA guidance distinguishes Great Britain from Northern Ireland. GB uses the UK medical-device framework and applicable conformity/registration routes; NI applies the EU device framework, with CE or, where applicable, CE UKNI marking rather than UKCA alone. Check the actual product’s intended purpose and documentation. These are market rules, not evidence of operator competence.[11]iMHRA guidance separates GB and NI device-market routes; conformity and registration do not establish a practitioner's permission or competence to operate the device.Inferred from adjacent evidence[11] MHRA. Regulating medical devices in the UK. Updated 20 February 2026. Accessed 16 September 2026.Tier 1
Practitioner scope in the four nations
Checked on 16 September 2026:
- England: the 2023 consultation placed plasma ablation/fibroblast in a proposed amber category. The 2025 response describes further scheme development; these documents are not themselves an operative practitioner licence.[12, 13]England's 2023 consultation proposed amber classification for plasma ablation/fibroblast; the 2025 response describes further licensing development and is not itself an operative licence.Directly tested by the source[12] DHSC. The licensing of non-surgical cosmetic procedures in England. Consultation, 2023. Accessed 16 September 2026.Tier 1[13] DHSC. The licensing of non-surgical cosmetic procedures in England: consultation response. 7 August 2025.Tier 1
- Scotland: S.S.I. 2026/87 defines procedures including electrocautery. Whether a particular plasma service meets a definition depends on its actual technique. The licence requirement under this order does not begin before 6 September 2027, with transitional provisions and exclusions to consider.[14]iScottish SSI 2026/87 includes electrocautery among defined procedures, with no licence required under that order before 6 September 2027 and transitional/exclusion provisions. The actual plasma technique must be checked against the definitions.Inferred from adjacent evidence[14] Scottish Ministers. Civic Government (Scotland) Act 1982 (Licensing of Non-surgical Procedures) Order 2026. S.S.I. 2026/87, articles 3–6 and schedule 1.Tier 1
- Wales: the special-procedures licensing scheme covers acupuncture, body piercing, electrolysis and tattooing. It does not supply a general plasma-treatment permission; check the proposed service with the relevant authority.[15]iThe Welsh four-procedure scheme is not general plasma-treatment authorisation; a proposed service needs its own local scope assessment.Inferred from adjacent evidence[15] Welsh Government. Licensing scheme for special procedures. Updated 30 July 2026.Tier 1
- Northern Ireland: the April 2026 ministerial answer reported no current plans for a broad cosmetic licensing scheme in the remaining mandate. That statement does not remove existing professional, premises or other applicable obligations.[16]iThe April 2026 NI answer concerns plans during the remaining mandate, not unrestricted permission to practise cosmetic procedures.Inferred from adjacent evidence[16] Northern Ireland Assembly. AQW 41857/22–27. Minister of Health answer, 1 April 2026.Tier 1
Contraindications and cautions#
Defer an unexplained lesion for diagnosis. A presumed skin tag can be another lesion, including skin cancer. The ability of equipment to destroy a lesion does not answer whether it should be destroyed.[10]iA lesion thought to be a skin tag may instead be another lesion, including skin cancer; appropriate diagnosis should precede destructive cosmetic treatment.Inferred from adjacent evidence[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
Assess eyelid symptoms before appearance. Sudden drooping, eye pain, photophobia or altered vision are reasons for medical or eye-care assessment, not a routine skin-tightening consultation.[8, 9]Suspected chemical eye/skin burns need emergency assessment; sudden eyelid drooping, eye pain, photophobia, inability to open an eye or vision changes need urgent medical/eye assessment rather than routine cosmetic correction.Directly tested by the source[8] NHS. Acid and chemical burns. Reviewed 5 June 2024. Accessed 16 September 2026.Tier 4[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4
Selection should also consider current skin condition, previous pigmentation or scar problems, healing history and the proposed treatment area. These are clinical assessment priorities given the tissue injury and reported complications, not a validated universal screening score. Use the current instructions for the exact device to establish its contraindications, required protection and restrictions; the small studies do not supply a class-wide exclusion list.[1, 2, 9, 10]iSelection should identify the device and permitted use, diagnose the skin or eyelid concern, consider healing/pigment/scar history, and establish competence, protection, aftercare and access to clinical review. Device instructions and clinical assessment govern exclusions.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
Clinical uses and the evidence behind them#
Upper-eyelid skin laxity
Rossi and colleagues studied ten white women aged 40–72, with phototypes I–III, treated on the upper eyelids with Plexr. After three monthly sessions, assessment 4–6 weeks after the final sessionshowed improvement in eyelid appearance. The mean change was 2.6 grades on the study’s 0–9 scale. This was a small uncontrolled pilot, so it provides a promising observation rather than a comparison with surgery, observation alone or another established treatment. The authors reported no significant commercial interest; a separate funding statement was not identified. The regimen is reported as research, not a treatment recommendation.[3]An uncontrolled Plexr study in ten white women aged 40–72, phototypes I–III, reported upper-eyelid appearance improvement 4–6 weeks after three monthly sessions. It provides a promising device/site-specific observation, not a class-wide responder rate.Directly tested by the source[3] Rossi E, Farnetani F, Trakatelli M, Ciardo S, Pellacani G. Clinical and Confocal Microscopy Study of Plasma Exeresis for Nonsurgical Blepharoplasty of the Upper Eyelid: A Pilot Study. Dermatol Surg. 2018;44(2):283–290. doi:10.1097/DSS.0000000000001267. PMID:28930794.Tier 3
Comparison of two energy approaches
A Brazilian study randomised 20 women, with 18 completing, to a Spectra Artis direct plasma jet or New Skin electrocarbonisation for upper-eyelid wrinkles. Three monthly treatments were assessed 30 days after the final session. Both groups improved photographically, and the authors favoured plasma for histological changes and fewer reactions.[4]In a Brazilian randomised upper-eyelid comparison, 20 women entered and 18 completed three monthly treatments with plasma jet or electrocarbonisation and 30-day follow-up. Both improved photographically; authors favoured plasma, but histology involved only one woman per arm, age reporting conflicts and exclusion after complications weaken interpretation.Directly tested by the source[4] Meyer PF, Borges FS, Soares CD, et al. Plasma Jet versus Electrocarbonization in the Treatment of Wrinkles of the Upper Palpebral Region. J Clin Aesthet Dermatol. 2024;17(1):33–40. PMID:38298752.Tier 2
The strength of that conclusion is constrained by the study’s design and reporting. Histology came from two women, one per arm; multiple microscopic fields do not create additional independent patients. The reported mean ages conflict with the eligibility age range, and the methods allowed exclusion following complications, so the study cannot establish a reliable comparative complication rate. The publication reports no funding or conflicts.[4]In a Brazilian randomised upper-eyelid comparison, 20 women entered and 18 completed three monthly treatments with plasma jet or electrocarbonisation and 30-day follow-up. Both improved photographically; authors favoured plasma, but histology involved only one woman per arm, age reporting conflicts and exclusion after complications weaken interpretation.Directly tested by the source[4] Meyer PF, Borges FS, Soares CD, et al. Plasma Jet versus Electrocarbonization in the Treatment of Wrinkles of the Upper Palpebral Region. J Clin Aesthet Dermatol. 2024;17(1):33–40. PMID:38298752.Tier 2
For a client whose concern is upper-eyelid appearance, these studies support discussion of a possible benefit from the studied devices in assessed patients. The available observations are short term and should remain tied to that anatomical site and study population.[3]An uncontrolled Plexr study in ten white women aged 40–72, phototypes I–III, reported upper-eyelid appearance improvement 4–6 weeks after three monthly sessions. It provides a promising device/site-specific observation, not a class-wide responder rate.Directly tested by the source[3] Rossi E, Farnetani F, Trakatelli M, Ciardo S, Pellacani G. Clinical and Confocal Microscopy Study of Plasma Exeresis for Nonsurgical Blepharoplasty of the Upper Eyelid: A Pilot Study. Dermatol Surg. 2018;44(2):283–290. doi:10.1097/DSS.0000000000001267. PMID:28930794.Tier 3[4]In a Brazilian randomised upper-eyelid comparison, 20 women entered and 18 completed three monthly treatments with plasma jet or electrocarbonisation and 30-day follow-up. Both improved photographically; authors favoured plasma, but histology involved only one woman per arm, age reporting conflicts and exclusion after complications weaken interpretation.Directly tested by the source[4] Meyer PF, Borges FS, Soares CD, et al. Plasma Jet versus Electrocarbonization in the Treatment of Wrinkles of the Upper Palpebral Region. J Clin Aesthet Dermatol. 2024;17(1):33–40. PMID:38298752.Tier 2
Selecting a plasma device and treatment approach#
Start with the clinical goal: a diagnosed lesion, skin laxity or another concern. For an eyelid concern, assess whether the issue is skin appearance or a functional problem requiring an eye specialist.[1, 2, 9, 10]iSelection should identify the device and permitted use, diagnose the skin or eyelid concern, consider healing/pigment/scar history, and establish competence, protection, aftercare and access to clinical review. Device instructions and clinical assessment govern exclusions.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
A useful treatment record identifies:
- The manufacturer, model, intended use and market-conformity documentation.[11]iMHRA guidance separates GB and NI device-market routes; conformity and registration do not establish a practitioner's permission or competence to operate the device.Inferred from adjacent evidence[11] MHRA. Regulating medical devices in the UK. Updated 20 February 2026. Accessed 16 September 2026.Tier 1
- The diagnosis or appearance goal and the actual anatomical site.[1, 2, 9, 10]iSelection should identify the device and permitted use, diagnose the skin or eyelid concern, consider healing/pigment/scar history, and establish competence, protection, aftercare and access to clinical review. Device instructions and clinical assessment govern exclusions.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
- Relevant healing, pigmentation and scar history, with clinical assessment where needed.[1, 2, 9, 10]iSelection should identify the device and permitted use, diagnose the skin or eyelid concern, consider healing/pigment/scar history, and establish competence, protection, aftercare and access to clinical review. Device instructions and clinical assessment govern exclusions.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
- Device-specific protection, aftercare and a route to review unexpected symptoms.[8, 9]Suspected chemical eye/skin burns need emergency assessment; sudden eyelid drooping, eye pain, photophobia, inability to open an eye or vision changes need urgent medical/eye assessment rather than routine cosmetic correction.Directly tested by the source[8] NHS. Acid and chemical burns. Reviewed 5 June 2024. Accessed 16 September 2026.Tier 4[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4
Training and insurance should match the actual procedure, not just its trade name. Current manufacturer instructions and applicable local requirements govern use. No universal energy, spacing, number of dots or retreatment interval is prescribed here.
Adverse effects and their management#
Healing reactions:pain, swelling, redness and crusting are described by Health Canada. In Rossi’s ten-person eyelid study, scabs lasted 3–7 days and redness persisted for several weeks. Those observations are useful for discussing recovery, but should not be converted into a fixed downtime promise. Provide device-specific aftercare and review recovery in relation to the original treatment area.[2, 3]Crusting, swelling and redness can follow treatment. In Rossi's ten-person upper-eyelid study scabs lasted 3–7 days and erythema persisted several weeks; that is a study observation, not a universal downtime guarantee.Directly tested by the source[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1[3] Rossi E, Farnetani F, Trakatelli M, Ciardo S, Pellacani G. Clinical and Confocal Microscopy Study of Plasma Exeresis for Nonsurgical Blepharoplasty of the Upper Eyelid: A Pilot Study. Dermatol Surg. 2018;44(2):283–290. doi:10.1097/DSS.0000000000001267. PMID:28930794.Tier 3
Pigment change: Nipshagen and colleagues described two women, aged 37 and 61, with phototypes II and IV, who developed lower-periorbital post-inflammatory hyperpigmentation after PlexR treatment. Pigmentation persisted for months despite reported sunscreen use. No conflict was declared and separate funding was not stated. This case report documents the possibility and persistence of the complication; it does not provide a dependable incidence estimate. Persistent pigmentation needs assessment rather than an automatic additional energy treatment.[5]Two women aged 37 and 61, phototypes II and IV, developed lower-periorbital PIH lasting months after PlexR treatment; their report does not establish incidence.Directly tested by the source[5] Nipshagen MD, Velthuis PJ, Mosmuller DGM. Periorbital postinflammatory hyperpigmentation after plasma exeresis. Dermatol Ther. 2020;33(3):e13404. doi:10.1111/dth.13404. PMID:32279389.Tier 3
Periocular exposure: a case report described a 60-year-old woman with bilateral chemical eye injury during a salon plasma-fibroblast procedure. The injury was attributed to EMLA anaesthetic cream entering the eyes, not demonstrated damage from plasma energy. No specific grant or competing interests were declared. The case illustrates why the whole procedure—including accompanying products—belongs in the safety assessment. Suspected chemical eye injury needs emergency care.[6]A reported bilateral chemical eye injury in a 60-year-old woman was attributed to EMLA cream during periocular treatment, not demonstrated plasma-energy corneal injury.Directly tested by the source[6] Patel S, Shamdas M, Cobb C. Plasma fibroblast skin tightening treatment resulting in bilateral chemical eye injury secondary to EMLA cream: a case report. BMC Ophthalmol. 2020;20:342. doi:10.1186/s12886-020-01613-8. PMID:32831067.Tier 3[8, 9]Suspected chemical eye/skin burns need emergency assessment; sudden eyelid drooping, eye pain, photophobia, inability to open an eye or vision changes need urgent medical/eye assessment rather than routine cosmetic correction.Directly tested by the source[8] NHS. Acid and chemical burns. Reviewed 5 June 2024. Accessed 16 September 2026.Tier 4[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4
Excessive tissue injury: a 44-year-old woman in Belgium received emergency assessment and outpatient care for bilateral second-degree breast burns after attempted plasma tightening. Dyschromic scars remained at six months; the report did not describe hypertrophic or keloid scars. The authors declared no funding or relevant financial relationships. It is evidence of a possible serious harm in that treatment context, not a rate for eyelid treatment or every device. Health Canada also identifies infection and scarring as potential complications of misuse. Significant injury requires medical assessment and documentation of the device and exposure.[7]A 44-year-old woman received emergency assessment and outpatient care for second-degree breast burns after attempted plasma tightening and had dyschromic scars at six months; this documents a possible injury rather than a category-wide complication rate.Directly tested by the source[7] Goulliart S, Jaber G, Miszewska C, Pollio C, Ortiz S. The Dangers of Social Media as an Information Source: A Case Report of a Burn After Attempted Breast Tightening Using a PlasmaPen. Cureus. 2024;16(11):e72885. doi:10.7759/cureus.72885. PMID:39624522.Tier 3[2]Health Canada describes potential burns, infection, scarring and eye injury from misuse in addition to pain, redness, swelling, crusting and pigment change.Directly tested by the source[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1
Referral and scope boundaries#
Suspected chemical burns of the eye or skin require emergency assessment. NHS advice is to call 999 for acid or chemical burns. Do not postpone urgent care to wait for a cosmetic follow-up appointment.[8, 9]Suspected chemical eye/skin burns need emergency assessment; sudden eyelid drooping, eye pain, photophobia, inability to open an eye or vision changes need urgent medical/eye assessment rather than routine cosmetic correction.Directly tested by the source[8] NHS. Acid and chemical burns. Reviewed 5 June 2024. Accessed 16 September 2026.Tier 4[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4
Sudden eyelid drooping, eye pain, inability to open the eye, light sensitivity or visual change warrant urgent GP, optician or NHS 111 assessment under NHS eyelid guidance. These symptoms should not be reclassified as a cosmetic laxity problem.[8, 9]Suspected chemical eye/skin burns need emergency assessment; sudden eyelid drooping, eye pain, photophobia, inability to open an eye or vision changes need urgent medical/eye assessment rather than routine cosmetic correction.Directly tested by the source[8] NHS. Acid and chemical burns. Reviewed 5 June 2024. Accessed 16 September 2026.Tier 4[9] NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4
For a lesion proposed for removal, establish the diagnosis first. Where it is uncertain, refer for clinical assessment rather than destructive treatment. Aesthetic competence with a device and competence to diagnose a lesion are separate requirements.[10]iA lesion thought to be a skin tag may instead be another lesion, including skin cancer; appropriate diagnosis should precede destructive cosmetic treatment.Inferred from adjacent evidence[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
Mechanism of action#
In the FDA-described devices, radiofrequency electrical energy generates an ionised air pathway and an arc to tissue, producing a local tissue effect. Health Canada describes focused electrical injury followed by healing. The visible treated area and subsequent recovery are therefore part of the mechanism, not an unrelated side effect.[1, 2]iElectrical-arc plasma devices ionise air and deliver focused energy that removes, coagulates or injures tissue; the fibroblast name does not describe injection of cells.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1
The proposed relationship with fibroblasts, collagen and the wound-healing cascade concerns how injured tissue responds. Human studies have examined clinical appearance, confocal images and a very small histological sample. What each method can establish is important when explaining a collagen claim.[3]iRossi's confocal images showed altered fibre appearance after treatment; the study did not directly quantify new collagen production or fibroblast numbers.Inferred from adjacent evidence[3] Rossi E, Farnetani F, Trakatelli M, Ciardo S, Pellacani G. Clinical and Confocal Microscopy Study of Plasma Exeresis for Nonsurgical Blepharoplasty of the Upper Eyelid: A Pilot Study. Dermatol Surg. 2018;44(2):283–290. doi:10.1097/DSS.0000000000001267. PMID:28930794.Tier 3
Commonly misstated claims#
Images treated as a collagen-production measurement
Claim heard:“The eyelid study proved how much new collagen a plasma pen produces.”
Literature finding:Rossi’s study reported changes in the appearance of fibres on reflectance confocal microscopy. It did not directly measure new collagen production or count newly generated fibroblasts.[3]iRossi's confocal images showed altered fibre appearance after treatment; the study did not directly quantify new collagen production or fibroblast numbers.Inferred from adjacent evidence[3] Rossi E, Farnetani F, Trakatelli M, Ciardo S, Pellacani G. Clinical and Confocal Microscopy Study of Plasma Exeresis for Nonsurgical Blepharoplasty of the Upper Eyelid: A Pilot Study. Dermatol Surg. 2018;44(2):283–290. doi:10.1097/DSS.0000000000001267. PMID:28930794.Tier 3
Supported statement: The study provides human imaging observations alongside appearance improvement, not a quantified collagen-production result.
An established substitute for surgical blepharoplasty
Claim heard:“A plasma pen gives the same result as a surgical eyelift.”
Literature finding: No controlled evidence establishing equivalent outcomes to surgical blepharoplasty was located. The search included plasma exeresis, blepharoplasty, randomised surgery comparisons and primary eyelid-treatment reports. It cannot exclude unpublished work.[no source found]A bounded search on 16 September 2026 did not locate controlled evidence establishing equivalent outcomes to surgical blepharoplasty for electrical-arc plasma pens.We looked and found no source either way
Supported statement:Surgical equivalence could not be verified; selection should be based on the person’s assessed problem and the evidence for the actual option.
A name treated as evidence of interchangeability
Claim heard:“Results for one plasma system apply to every fibroblast pen.”
Literature finding: The retained clinical papers identify different devices and a particular treatment site. The FDA technical document likewise describes named equipment and its intended purpose, rather than a generic commercial category.[1]FDA K223440 clears the named prescription-use Plasma MD/Plasma + devices for removal/destruction of skin lesions and coagulation of tissue, not every plasma pen or a general claim of surgical-equivalent eyelid lifting.Directly tested by the source[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1
Supported statement: Keep the device, indication and anatomical site attached to the result being discussed.
Areas of remaining uncertainty#
- Which patients are most likely to benefit? The small studies make individual assessment and realistic consent especially important; record the baseline concern and review the same outcome afterwards.[4]In a Brazilian randomised upper-eyelid comparison, 20 women entered and 18 completed three monthly treatments with plasma jet or electrocarbonisation and 30-day follow-up. Both improved photographically; authors favoured plasma, but histology involved only one woman per arm, age reporting conflicts and exclusion after complications weaken interpretation.Directly tested by the source[4] Meyer PF, Borges FS, Soares CD, et al. Plasma Jet versus Electrocarbonization in the Treatment of Wrinkles of the Upper Palpebral Region. J Clin Aesthet Dermatol. 2024;17(1):33–40. PMID:38298752.Tier 2
- How does recovery vary across skin types and treatment sites? Discuss relevant pigment and healing history and ensure follow-up can respond to an unexpected course.[5]Two women aged 37 and 61, phototypes II and IV, developed lower-periorbital PIH lasting months after PlexR treatment; their report does not establish incidence.Directly tested by the source[5] Nipshagen MD, Velthuis PJ, Mosmuller DGM. Periorbital postinflammatory hyperpigmentation after plasma exeresis. Dermatol Ther. 2020;33(3):e13404. doi:10.1111/dth.13404. PMID:32279389.Tier 3
- How should a particular system be classified locally? Obtain its technical description and intended-use documents before asking the relevant authority about the proposed service.[11]iMHRA guidance separates GB and NI device-market routes; conformity and registration do not establish a practitioner's permission or competence to operate the device.Inferred from adjacent evidence[11] MHRA. Regulating medical devices in the UK. Updated 20 February 2026. Accessed 16 September 2026.Tier 1
Frequently asked questions#
What does the word fibroblast mean in the treatment name?
It refers to the tissue-response rationale. The pen delivers electrical energy; it is not an injection of fibroblast cells.[1, 2]iElectrical-arc plasma devices ionise air and deliver focused energy that removes, coagulates or injures tissue; the fibroblast name does not describe injection of cells.Inferred from adjacent evidence[1] US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1[2] Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1
What should a consultation establish first?
The actual skin or eyelid problem, the treatment goal and the specific device being proposed. A lesion or functional eye symptom may need clinical assessment before a cosmetic option is considered.[10]iA lesion thought to be a skin tag may instead be another lesion, including skin cancer; appropriate diagnosis should precede destructive cosmetic treatment.Inferred from adjacent evidence[10] Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4
Should the aftercare plan cover products used with the procedure?
Yes. Accompanying products are part of the exposure, especially around the eyes, and should be included in the treatment record and safety plan.[6]A reported bilateral chemical eye injury in a 60-year-old woman was attributed to EMLA cream during periocular treatment, not demonstrated plasma-energy corneal injury.Directly tested by the source[6] Patel S, Shamdas M, Cobb C. Plasma fibroblast skin tightening treatment resulting in bilateral chemical eye injury secondary to EMLA cream: a case report. BMC Ophthalmol. 2020;20:342. doi:10.1186/s12886-020-01613-8. PMID:32831067.Tier 3
References#
Each source is graded by evidence tier. Tier 4 material (manufacturer documents, expert consensus, practitioner experience) is useful for protocol and context, and is never presented as equivalent to independent clinical evidence.
- US Food and Drug Administration. K223440: Plasma MD and Plasma +. Clearance letter, indications and 510(k) summary. 2 March 2023.Tier 1Supports: Named US prescription-use devices, intended removal/destruction of skin lesions and coagulation of tissue, and electrically generated plasma-arc mechanism. Not all plasma pens, a UK operator licence or a surgical-equivalence finding.Funding / interest: FDA clearance with manufacturer-submitted technical summary; not independently funded clinical efficacy evidence.
- Health Canada. Plasma pens advisory, originally 2018; updated 11 May 2022. Accessed 16 September 2026.Tier 1Supports: Focused electrical energy and controlled-burn mechanism; expected reactions and potential excessive burns, scarring, infection and eye injury. Updated statement that certain pens are authorised for healthcare professionals in Canada.Funding / interest: Canadian regulator safety advisory; not a manufacturer efficacy study or UK legal instrument.
- Rossi E, Farnetani F, Trakatelli M, Ciardo S, Pellacani G. Clinical and Confocal Microscopy Study of Plasma Exeresis for Nonsurgical Blepharoplasty of the Upper Eyelid: A Pilot Study. Dermatol Surg. 2018;44(2):283–290. doi:10.1097/DSS.0000000000001267. PMID:28930794.Tier 3Supports: Uncontrolled Plexr upper-eyelid study in ten white women aged 40–72, phototypes I–III, assessed 4–6 weeks after three monthly treatments; photographic improvement, confocal appearance and healing observations.Funding / interest: Authors declared no significant interest with commercial supporters. Separate funding statement not identified in the full paper; independent funding is not established.
- Meyer PF, Borges FS, Soares CD, et al. Plasma Jet versus Electrocarbonization in the Treatment of Wrinkles of the Upper Palpebral Region. J Clin Aesthet Dermatol. 2024;17(1):33–40. PMID:38298752.Tier 2Supports: Twenty women randomised, eighteen completing a Brazilian upper-eyelid active-comparator study; three monthly sessions and 30-day follow-up. Histological substudy comprised only two women, one per arm; eligibility/age inconsistency and post-complication exclusion constrain interpretation.Funding / interest: Publication reports no funding and no conflicts of interest.
- Nipshagen MD, Velthuis PJ, Mosmuller DGM. Periorbital postinflammatory hyperpigmentation after plasma exeresis. Dermatol Ther. 2020;33(3):e13404. doi:10.1111/dth.13404. PMID:32279389.Tier 3Supports: Two women aged 37 and 61, phototypes II and IV, with persistent lower-periorbital pigmentation after PlexR treatment; clinical case reports, not a prospectively measured incidence study.Funding / interest: No conflicts declared; a separate funding statement was not found in the retrieved original letter.
- Patel S, Shamdas M, Cobb C. Plasma fibroblast skin tightening treatment resulting in bilateral chemical eye injury secondary to EMLA cream: a case report. BMC Ophthalmol. 2020;20:342. doi:10.1186/s12886-020-01613-8. PMID:32831067.Tier 3Supports: A 60-year-old woman sustained bilateral chemical eye injury from peri-procedural EMLA exposure; the reported cause was anaesthetic cream, not demonstrated plasma-energy corneal injury.Funding / interest: No specific grant or competing interests declared.
- Goulliart S, Jaber G, Miszewska C, Pollio C, Ortiz S. The Dangers of Social Media as an Information Source: A Case Report of a Burn After Attempted Breast Tightening Using a PlasmaPen. Cureus. 2024;16(11):e72885. doi:10.7759/cureus.72885. PMID:39624522.Tier 3Supports: A 44-year-old woman in Belgium with bilateral second-degree breast burns after attempted tightening, emergency assessment and outpatient burn care, and dyschromic scars at six months. Not a complication rate or an unambiguous identification of one manufacturer.Funding / interest: No funding or relevant financial relationships declared.
- NHS. Acid and chemical burns. Reviewed 5 June 2024. Accessed 16 September 2026.Tier 4Supports: Emergency assessment for chemical burns of skin or eyes; public patient information rather than a formal evidence-graded treatment guideline.Funding / interest: NHS public information; no commercial sponsor stated.
- NHS. Eyelid problems. Reviewed 17 November 2023. Accessed 16 September 2026.Tier 4Supports: Urgent assessment for sudden drooping, eye pain, visual change, inability to open the eye or photophobia; not a plasma-treatment complication rate.Funding / interest: NHS public information; no commercial sponsor stated.
- Ludmann P. Skin tags: Why they develop, and how to remove them. American Academy of Dermatology. Updated 1 May 2023; reviewed by Gallo RL, Geraghty L and Lipner SR.Tier 4Supports: Other lesions, including skin cancer, can be mistaken for skin tags; appropriate diagnosis precedes removal.Funding / interest: Professional patient reference; article-specific sponsorship not located on the retrieved page.
- MHRA. Regulating medical devices in the UK. Updated 20 February 2026. Accessed 16 September 2026.Tier 1Supports: Separate GB and Northern Ireland market-conformity/registration frameworks; not operator competence, clinical efficacy or blanket approval of a device category.Funding / interest: Official UK market-regulation guidance; not a clinical study.
- DHSC. The licensing of non-surgical cosmetic procedures in England. Consultation, 2023. Accessed 16 September 2026.Tier 1Supports: Plasma ablation/plasma fibroblast included in proposed amber procedure category; this is a consultation proposal, not an operative licence.Funding / interest: Government policy consultation; not clinical evidence.
- DHSC. The licensing of non-surgical cosmetic procedures in England: consultation response. 7 August 2025.Tier 1Supports: Further development of England licensing; the response does not itself commence a practitioner-licensing scheme.Funding / interest: Official government response; not a clinical study.
- Scottish Ministers. Civic Government (Scotland) Act 1982 (Licensing of Non-surgical Procedures) Order 2026. S.S.I. 2026/87, articles 3–6 and schedule 1.Tier 1Supports: Defined Scottish procedure classes include electrocautery; application to a particular plasma system requires its actual mechanism. Licensing requirement does not begin before 6 September 2027 and transitional provisions/exclusions apply.Funding / interest: Primary Scottish legislation; not a clinical study.
- Welsh Government. Licensing scheme for special procedures. Updated 30 July 2026.Tier 1Supports: Welsh scheme covers acupuncture, body piercing, electrolysis and tattooing; it is not a general licence for plasma treatment.Funding / interest: Official Welsh government guidance; not a clinical study.
- Northern Ireland Assembly. AQW 41857/22–27. Minister of Health answer, 1 April 2026.Tier 1Supports: At the date of the answer, no current departmental plans for a broad non-surgical cosmetic licensing scheme during the remaining mandate; not exemption from existing obligations.Funding / interest: Official parliamentary answer; not a clinical study.