Apyx Medical receives FDA 510(k) clearance for Renuvion to treat loose skin on neck and chin

Apyx Medical Corp

FDA clearance for Renuvion APR Handpiece for subcutaneous procedures to improve appearance of lax skin in neck and submental region.
Renuvion is now the only FDA-cleared device for improving loose skin on neck and chin; targets ~200,000 annual US neck contouring procedures.
Limited launch expected by end of Q3 2022, full commercialization by end of 2022.
Clearance supported by safety and efficacy data from a U.S. IDE clinical study; results announced July 8, 2022.
This is the second regulatory clearance for a specific clinical indication in less than two months.

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