Apyx Medical Gets 510(k) Clearance From FDA for Renuvion Dermal Handpiece
May 26 2022 - 09:28AM
Dow Jones News
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)
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