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Apyx Medical Corporation Receives FDA 510(k) Clearance for the Use of Renuvion® to Coagulate and Contract Soft Tissues, Including Subcutaneous Tissue, Where Needed

Monday, February 27, 2023

Apyx Medical Corporation, the manufacturer of a proprietary helium plasma and radiofrequency technology marketed and sold as Renuvion®, today announced it has received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the use of the Renuvion APR Handpiece “for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.”

“We are pleased to receive this 510(k) clearance with specific indication language related to the use of the Renuvion APR Handpiece for the contraction of soft tissues, including subcutaneous tissue, where needed,” said Charlie Goodwin, President and Chief Executive Officer. “The receipt of this 510(k) clearance further demonstrates the safety and effectiveness of Renuvion, and our commitment to working with the FDA to secure specific clinical indications related to its use. To this end, our 510(k) submission to obtain an additional specific indication for the use of the Renuvion APR Handpiece for the contraction of subcutaneous soft tissues where needed following liposuction remains under review by the FDA, and we look forward to receiving the Agency’s decision.”

 

Source: businesswire.com

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