Apyx Medical Files 510(k) for Dermal Resurfacing Device

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.