The U.S. Food and Drug Administration (FDA) announced 510(k) clearance (pre-market notification) of Apyx Medical’s (NASDAQ:APYX) Renuvion Dermal Handpiece for specific dermal resurfacing procedures.
The company said that the Renuvion Dermal Handpiece is indicated for dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.
Charlie Goodwin, President and Chief Executive Officer, said, "We are very pleased to receive FDA 510(k) clearance with a specific clinical indication that enables Apyx Medical to market and sell our Renuvion Cosmetic Technology to surgeons and patients for use in approximately 200,000 wrinkle reduction procedures performed in the U.S. annually”.
Apyx Medical plans for a limited launch of Renuvion for this indication in the third quarter of 2022, while full commercial launch is expected by the end of 2022.
Price Check: Shares of Apyx Medical are trading high 35 percent at $5.01 in Thursday’s regular session, according to Benzinga Pro.
Image: Panchenko Vladimir shutterstock.com
