Apyx 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.
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
Feb 01, 2023
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