FDA OKs Apyx’s Renuvion Micro Handpiece

Apyx Medical Corporation, maker of proprietary Renuvion helium plasma and radiofrequency (RF) tech, has gained U.S. Food and Drug Administration (FDA) 510(k) clearance for the Renuvion Micro Handpiece.
 
The handpiece was cleared with the indication for delivery of RF energy and/or helium plasma where soft tissue coagulation/contraction is necessary. Soft tissue also includes subcutaneous tissue.
 
“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,” Charlie Goodwin, Surmodics president and CEO told the press. “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.”
 
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.”
 
Renuvion helium plasma technology is used in the cosmetic surgery market. It provides controlled heat to tissue to achieve desired results for surgeons. Apyx’s Renuvion APR handpiece was cleared in the U.S. in April to deliver RF and/or helium plasma where coagulation/contraction of soft tissue is needed, including subcutaneous tissue.