Plasma Microneedling

Plasma microneedling is a new medical device raising a number of questions. The most common question received is, “is it FDA cleared or FDA approved?”

Based on a search of the De Novo, PMA, and 510(k) databases at the time of this post, no entry could be found for plasma microneedling. That means any plasma microneedling device currently sold is an unapproved medical device subject to FDA scrutiny and enforcement, including a Warning Letter and product recall. It’s possible a device could be currently under review with CDRH, but even so, no device can be marketed or sold until final clearance is secured.

Plasma devices are generally subject to pre-market clearance, such as those cleared as Electrosurgical conductive gas coagulation devices (See, K030028). It’s also important to remember how the FDA defined microneedling (previous post here). That definition stated:

A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use. 

A plasma microneedling device does not mechanically puncture the skin. In all likelihood this is a new device type subject to a De Novo approval.

Any users should use the link above to the FDA databases to confirm whether a plasma microneedling device is cleared. If it isn’t, exercise caution since injuries from the use of unapproved medical device can impose a severe liability.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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