Therapy Areas: Devices
Apyx Medical Receives FDA 510(k) Clearance for the Use of Renuvion to Coagulate and Contract Soft Tissues, Including Subcutaneous Tissue, Where Needed
3 March 2023 - - US-based helium plasma and radiofrequency technology maker Apyx Medical Corp. (NASDAQ: APYX) has received 510(k) clearance from the US Food and Drug Administration 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," the company said.

Apyx Medical Corp. 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.