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Apyx Medical Corporation Announces FDA 510(k) Clearance for the Renuvion® Micro Handpiece
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 received 510(k) clearance from the U.S. Food and Drug Administration (“FDA”) for the Renuvion Micro Handpiece, a new addition to the Renuvion product family. The Renuvion Micro Handpiece is cleared with an indication “for the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed. Soft tissue includes subcutaneous tissue.”\n\n\n“The Renuvion Micro Handpiece represents a new addition to our Advanced Energy product portfolio, designed with the needs of our surgeon customers in the cosmetic surgery market in mind,” said Charlie Goodwin, President and Chief Executive Officer. “Most notably, our Renuvion Micro Handpiece features include a smaller instrument shaft, which is 10 cm long and 1.5mm wide, half the width of our Renuvion APR Handpiece. It complements our existing product portfolio, providing our customers with a new option to facilitate soft tissue contraction in those cases that may benefit from the use of a handpiece with a smaller profile. The Renuvion Micro Handpiece is designed for use with the Apyx One Console, our next-generation generator system which we launched at the beginning of 2023.”\n\n\nMr. Goodwin continued: “We are delighted to receive 510(k) clearance for the Renuvion Micro Handpiece and look forward to initiating our limited commercial launch of the product during the third quarter of this year.”\n\n\nAbout Apyx Medical Corporation:\n\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 J-Plasma® in the hospital surgical market. Renuvion and J-Plasma offer surgeons a unique ability to provide controlled heat to tissue to achieve their desired results. The Company also leverages its deep expertise and decades of experience in unique waveforms through 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.ApyxMedi...