Apyx Receives 510(k) Clearance for Renuvion Device

The FDA granted 510(k) clearance to Apyx Medical for its Renuvion device for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax skin in the neck and below the chin.

The device combines radiofrequency energy and helium plasma to deliver precise tissue contraction in a minimally-invasive procedure that directly treats the web-like structure of collagen fibers in the fat layer beneath the skin.

Renuvion is the only product that is FDA-cleared to improve the appearance of loose skin on the neck and chin, the company said.

“We’ve seen a considerable uptick in the market for these cosmetic procedures,” said Apyx Medical CEO Charlie Goodwin, who calls Renuvion “the next generation option for neck contouring procedures.”