Benzinga | Jun 1, 2021 07:37AM EDT

Apyx Medical Corporation Announces FDA 510(k) Submission For Use Of Renuvion In Dermal Resurfacing Procedures

Apyx Medical Corporation (NASDAQ:APYX) (the "Company"), a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion(r) in the cosmetic surgery market and J-Plasma(r) in the hospital surgical market, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration ("FDA"), which is intended to obtain a specific clinical indication for the use of Renuvion in dermal resurfacing procedures.

"Following the recent completion of our U.S. IDE clinical study evaluating the use of our Renuvion technology in dermal resurfacing procedures, we were pleased to submit our 510(k) premarket notification for this procedure category on May 28th," said Charlie Goodwin, President and Chief Executive Officer. "This submission is an important milestone that underscores our continued progress in pursuing specific clinical indications to market and sell Renuvion for target procedures in the cosmetic surgery market. I would like to thank our clinical and regulatory teams for their exceptional efforts which has made our recent progress possible, and look forward to the FDA's review of our submission."