regulatory
confidence high
sentiment positive
materiality 0.75
Apyx Medical gets FDA 510(k) clearance for Renuvion dermal resurfacing handpiece
Apyx Medical Corp
- Clearance for treatment of moderate to severe wrinkles, limited to Fitzpatrick skin types I–III.
- Addressable market of ~200,000 wrinkle reduction procedures annually in the U.S.
- Renuvion Dermal Handpiece indicated for specific dermal resurfacing procedures.
- Limited launch planned for Q3 2022; full commercialization targeted by end of 2022.
- CEO calls it 'one of the most important achievements' in the U.S. cosmetic surgery strategy.