Plasma Pen (Fibroblast) Treatment: FDA Warnings, Risks and Safer Alternatives
What plasma pen or fibroblast skin tightening is, what the FDA has said about plasma devices, reported risks like burns and scarring, and evidence-based alternatives.
Plasma pens (often marketed as "fibroblast" treatments) create tiny burns on the skin's surface to tighten and smooth it. The short answer: proceed with great caution. The FDA has issued a warning letter to a plasma pen maker whose devices lacked required clearance, and has warned about serious injuries from another plasma device used for skin procedures. Many treatments are performed by non-medical practitioners. Better-studied options exist.
How plasma pens work
The device creates a small electrical arc, or plasma, just above the skin, producing pinpoint burns and crusts. Manufacturers claim this tightens skin as it heals.
What the FDA has said
- Warning letter: In September 2022, the FDA issued a warning letter to Med Pen Concepts about its "Plasma MD" and "Plasma +" products, marketed to improve skin and used for "non-surgical eyelid lifts." The FDA said the devices were adulterated because they lacked an approved premarket approval application and misbranded because the company had not submitted a required 510(k) notification (FDA warning letter).
- Plasma device safety communication: In 2022, the FDA warned against using the Renuvion/J-Plasma device for skin resurfacing or skin contraction, which were not then cleared uses, citing reports of second- and third-degree burns, infection, skin color changes, scars, nerve damage, significant bleeding and gas accumulation under the skin, some requiring intensive care (FDA MedSun, April 2022). The FDA later cleared specific Renuvion handpieces for limited uses. Renuvion is a different, surgical device from handheld cosmetic plasma pens, but the warning shows the risks of plasma energy on skin.
Reported risks of plasma pen treatments
- Burns and prolonged crusting
- Scarring, including pitted scars
- Hyperpigmentation or hypopigmentation, especially in darker skin
- Infection
- Eye injury when used near the eyes
Who should avoid it
- Darker skin tones (higher risk of pigment changes)
- History of keloids or poor healing
- Active infection, cold sores or skin conditions in the area
- Anyone offered treatment by an untrained provider
Safer, better-studied alternatives
| Goal | Alternative |
|---|---|
| Fine lines and texture | Retinoids, chemical peels, laser resurfacing |
| Mild laxity | Microfocused ultrasound or radiofrequency |
| Hooded upper eyelids | Blepharoplasty with a qualified surgeon |
| Crow's feet | Botulinum toxin |
Topical tretinoin has controlled-trial evidence for photoaging (Weiss et al., JAMA, 1988).
If you still consider it
Ask what device will be used and whether it is FDA-cleared for that purpose, who performs it and their training, and how complications are handled. The FDA advises asking providers which devices they plan to use (FDA MedSun).
Frequently asked questions
Is plasma pen FDA approved? The FDA has taken action against a plasma pen maker for marketing devices without required clearance. Ask for documentation of clearance for the specific device and use.
Can it lift eyelids without surgery? That claim was among those cited in the FDA warning letter.
How long is recovery? Crusts typically last days, and redness can persist longer.
Is it safe at home? Home use raises the risk of burns and scarring.
This article is for educational purposes only and is not medical advice. Talk to a board-certified dermatologist about your situation.
Sources
- US FDA. Warning letter: Med Pen Concepts, 2022
- US FDA. MedSun newsletter, April 2022: Renuvion/J-Plasma safety communication
- Weiss JS et al. Topical tretinoin improves photoaged skin. JAMA. 1988. PubMed
