By Chris Wack

 

Apyx Medical Corp. said it has received 510(k) clearance from the U.S. Food and Drug Administration for the use of the Renuvion Dermal Handpiece for specific dermal resurfacing procedures.

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, the medical-device maker said.

The receipt of regulatory clearance reflects a strong safety and efficacy profile for Renuvion Cosmetic Technology, as demonstrated by the results of its U.S. IDE clinical study published in February, Apyx Medical said.

The company intends to begin a limited launch of Renuvion in the third quarter of 2022, with the goal of entering full commercialization by the end of 2022.

Apyx Medical shares were up 7%, to $3.97, in premarket trading.

 

Write to Chris Wack at chris.wack@wsj.com

 

(END) Dow Jones Newswires

May 26, 2022 09:13 ET (13:13 GMT)

Copyright (c) 2022 Dow Jones & Company, Inc.
Apyx Medical (NASDAQ:APYX)
Historical Stock Chart
From Jun 2022 to Jul 2022 Click Here for more Apyx Medical Charts.
Apyx Medical (NASDAQ:APYX)
Historical Stock Chart
From Jul 2021 to Jul 2022 Click Here for more Apyx Medical Charts.