APYX - Apyx Medical seeks FDA nod to expand use of Renuvion to improve lax skin

Apyx Medical (NASDAQ:APYX) submitted a 510(k) premarket notification to the U.S. Food and Drug Administration for expanding the use of Renuvion APR Handpiece to improve the appearance of lax (loose) skin in the neck and submental region. The application is aimed at expanding Renuvion APR Handpiece general indication to include use in subcutaneous dermatological and aesthetic procedures to achieve thermal coagulation/contraction to improve the appearance of lax skin in the neck and submental region. "The 510(k) is primarily supported by safety and effectiveness data from our U.S. IDE clinical study evaluating the use of Renuvion technology in the neck and submental region to improve the appearance of lax (loose) skin, and reflects a multi-year effort from our clinical and regulatory teams," said President and CEO Charlie Goodwin.

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Apyx Medical seeks FDA nod to expand use of Renuvion to improve lax skin