Apyx Medical Gets FDA 510(k) Clearance To Use Renuvion To Improve Appearance Of Loose Skin

(RTTNews) - Apyx Medical Corp. (APYX), a manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion, announced Monday that it has received 510(k) clearance from the U.S. Food and Drug Administration to use Renuvion APR Handpiece for certain skin contraction procedures.

The company said it expects to commence a limited launch of Renuvion for this indication by the end of the third quarter of 2022, with the goal of entering full commercialization by the end of 2022.

The Renuvion APR Handpieces are now indicated for use in subcutaneous dermatological and aesthetic procedures to improve the appearance of lax or loose skin in the neck and submental region.

Charlie Goodwin, President and Chief Executive Officer, said, "We can now market and sell Renuvion to surgeons and patients for use in the approximately 200,000 neck contouring procedures performed in the U.S. Annually."

Apyx Medical noted that Renuvion is now the only device that is FDA-cleared for improving the appearance of loose skin on the neck and chin.

The company's 510(k) submission for this indication was supported by safety and efficacy data from a U.S. IDE clinical study focused on the use of Renuvion in these procedures.

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