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Apyx Medical Corporation Announces FDA 510(k) Submission for the Use of Renuvion® in Dermal Resurfacing Procedures
CLEARWATER, Fla.--(BUSINESS WIRE)-- Apyx Medical Corporation (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies and the developer of
About this update from Apyx Medical Corporation
[{"type":"text","content":" CLEARWATER, Fla.--(BUSINESS WIRE)--\nApyx Medical Corporation (NASDAQ:APYX) (the “Company”), a maker of medical devices and supplies and the developer of Helium Plasma Technology, marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market, today announced it has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (“FDA”), which is intended to obtain a specific clinical indication for the use of Renuvion in dermal resurfacing procedures.\n\n“Following the recent completion of our U.S. IDE clinical study evaluating the use of our Renuvion technology in dermal resurfacing procedures, we were pleased to submit our 510(k) premarket notification for this procedure category on May 28th,” said Charlie Goodwin, President and Chief Executive Officer. “This submission is an important milestone that underscores our continued progress in pursuing specific clinical indications to market and sell Renuvion for target procedures in the cosmetic surgery market. I would like to thank our clinical and regulatory teams for their exceptional efforts which has made our recent progress possible, and look forward to the FDA’s review of our submission.”\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 in the cosmetic and surgical markets. Known for its innovative Helium Plasma Technology, Apyx is solely focused on bringing transformative solutions to the physicians and patients it serves. The company’s Helium Plasma Technology is marketed and sold as Renuvion® in the cosmetic surgery market and J-Plasma® in the hospital surgical market. Renuvion® offers surgeons and physicians a unique ability to provide controlled heat to the tissue to achieve their desired results. The J-Plasma® system allows surgeons to operate with a high level of precision while minimizing unintended tissue trauma. The Company also leverages its deep expertise and decades of experience in unique waveforms through original equipment manufacturing (OEM) agreements with other medical device manufacturers. For further information about the Company and its products, please refer to the Apyx Medical Corporation website at www.ApyxMedical.com.\n\nCautionary Statement on Forward-Looking...