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Apyx Medical Corporation Announces FDA 510(k) Submission for the Use of the Renuvion® APR Handpiece for the Coagulation of Subcutaneous Soft Tissues Where Needed, Following Liposuction
CLEARWATER, Fla.--(BUSINESS WIRE)-- Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), the manufacturer of a proprietary helium plasma and
About this update from Apyx Medical Corporation
[{"type":"text","content":" CLEARWATER, Fla.--(BUSINESS WIRE)--\nApyx Medical Corporation (NASDAQ:APYX) (the “Company”), the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced it has submitted a 510(k) premarket notification (“510(k) submission”) for the Renuvion APR Handpiece to the U.S. Food and Drug Administration (“FDA”), supported by a clinical study and real-world evidence. The 510(k) submission is intended to expand Renuvion’s indications for use to include a specific indication for the use of the Renuvion APR Handpiece for the coagulation of subcutaneous soft tissues where needed, following liposuction.\n\n“We are pleased to announce the submission of this request for 510(k) clearance for a new clinical indication, which is intended to enable Apyx Medical to market and sell our Renuvion APR Handpiece for use following liposuction,” said Charlie Goodwin, President and Chief Executive Officer. “This 510(k) submission leverages the substantial history of safe use of the Renuvion APR handpiece following liposuction procedures, and as such, Apyx Medical was able to assess the device based on a large set of retrospective chart reviews. Importantly, our analysis of Renuvion treatment adverse events, when compared to the real-world evidence gathered for liposuction treatments in the literature review, demonstrated that there are no new or increased risks for Renuvion procedures following liposuction procedures compared to liposuction alone.”\n\nMr. Goodwin continued: “We appreciate the continued engagement from the FDA in recent months as we prepared this important 510(k) submission, and we continue to believe the receipt of 510(k) clearance for this new clinical indication would directly address the remaining limitations of the Medical Device Safety Communication. We look forward to, and support, the FDA’s continued focus on ensuring that everyone in the industry is adhering to the safe and effective use of cosmetic surgery technologies, especially those used during or after liposuction procedures.”\n\nAbout Apyx Medical Corporation:\n\nApyx Medical Corporation is an advanced energy technology company with a passion for elevating people’s lives through innovative products, including its Helium Plasma Technology products marketed and sold as Renuvion® in the cosmetic surgery market and...