![FDA, FTC and DOJ Enforcement of Medical Device Regulations FDA, FTC and DOJ Enforcement of Medical Device Regulations](https://www.fdanews.com/ext/resources/Book-Covers-2/BFFDEMDR-COVER.png?height=200&t=1685733565&width=200)
Home » Apyx Medical Files 510(k) for Dermal Resurfacing Device
Apyx Medical Files 510(k) for Dermal Resurfacing Device
![Apyx Medical logo](https://www.fdanews.com/ext/resources/test/Device_Images6/Apyx-Medical-logo.gif?t=1622580942&width=430)
Florida-based Apyx Medical has submitted a 510(k) premarket notification to the FDA for use of Renuvion, its nonsurgical dermal resurfacing device.
The device, which uses radio waves to convert helium to a cold plasma, can rapidly heat tissue and then cool it back down to baseline temperatures in less than a second.
The device enables surgeons to deliver heat to the tissue with a high level of precision while minimizing unintended tissue trauma. The product is marketed as Renuvion in the cosmetic surgery market and J-Plasma in the hospital surgical market.
Upcoming Events
-
21Oct