Plasma pens are a new and popular cosmetic treatment option that have gained a lot of attention in recent years. While plasma pens have been used for many years overseas, very few plasma pens have been FDA-cleared for use in the US. The FDA has issued warnings to consumers and health care providers about the potential risks associated with the use of non FDA-cleared plasma pens for cosmetic treatments.
Plasma pens work by creating an electrical discharge that delivers an ionized gas, or plasma, to the skin. This plasma can be used to tighten sagging skin, reduce wrinkles, and improve the appearance of the skin. However, the FDA has not approved most plasma pens that are available for aesthetic use and has even issued warnings against the use of certain devices for certain aesthetic procedures. Sorry – I won’t name names, but there are several out there.
The plasma pens that the FDA has approved are able to deliver depth of penetration to the papillary dermis (upper levels) at the low setting to treat minor skin imperfections, such as skin tags, hyperpigmentation, crepey skin & wrinkles.
To check to see if the plasma pen you are looking at has been FDA approved, you can search the FDA premarket 510(k) database here. If the pen you are looking at is not listed in this database, DO NOT PURCHASE IT! You are undoubtedly looking at a pen that blends RF technology with Plasma or even worse, only uses RF, which can create significant thermal damage and possibly harm your client.
I have looked up many of the pens that claim to be FDA-approved, and most of them are not EVEN THOUGH THE DOCTORS USING THE PEN SAY THEY ARE! This is SCARY to me and just proves how much misinformation is currently out there about plasma pens. And keep in mind – if you are using a ‘plasma’ pen that is NOT FDA-approved, you are likely not going to be covered by your insurance company if you do have any issues!
I don’t know of any states where an esthetician is allowed to use a plasma pen without being under the supervision of a medical doctor. It is wise to call your state board to double-check before purchasing a plasma pen.
You should expect to pay at least $15K – $20K for an FDA-approved plasma pen. Anything less than that, and you are purchasing a cheap toy (yes – several thousand dollars is still a cheap toy!) that carries the very real risk of damaging your client. Protect your license by doing your research, and make 100% sure that the device you are purchasing is 1. FDA-approved 2. Covered by your insurance company 3. Sold by a company that provides OUTSTANDING training.
Doing due diligence is imperative to helping you choose the correct plasma device for your aesthetic or medical practice, and will help you maintain the integrity of your medical or aesthetic license.
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