Apyx Medical Corporation 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.” It complements existing product portfolio, providing 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, next-generation generator system which launched at the beginning of 2023.