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
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
A microneedling device for aesthetic use is a device using one or more needles to mechanically puncture and injure skin tissue for aesthetic use.
Any users should use the link above to the FDA databases to confirm whether a plasma
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