# 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.

Canonical: https://antiagingcare.org/blog/plasma-pen-fibroblast-treatment
HTML version: https://antiagingcare.org/blog/plasma-pen-fibroblast-treatment
Author: Anti Aging Care Editorial Team
Published: 2025-11-25
Updated: 2026-10-24
Category: Treatments

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](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/med-pen-concepts-llc-632974-09152022)).
- **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](https://www.fda.gov/medical-devices/medsun-newsletters/medsun-newsletter-april-2022-volume-22-issue-4)). 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](https://pubmed.ncbi.nlm.nih.gov/3336176/)).

## 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](https://www.fda.gov/medical-devices/medsun-newsletters/medsun-newsletter-april-2022-volume-22-issue-4)).

## 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](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/med-pen-concepts-llc-632974-09152022)
- US FDA. [MedSun newsletter, April 2022: Renuvion/J-Plasma safety communication](https://www.fda.gov/medical-devices/medsun-newsletters/medsun-newsletter-april-2022-volume-22-issue-4)
- Weiss JS et al. Topical tretinoin improves photoaged skin. *JAMA*. 1988. [PubMed](https://pubmed.ncbi.nlm.nih.gov/3336176/)