Apyx Medical today announced it received FDA 510(k) clearance for its Renuvion Micro Handpiece.
The Micro Handpiece is the latest addition to the company’s Renuvion product line. It is cleared with an indication for the delivery of radiofrequency (RF) energy or helium plasma where coagulation and contraction of soft tissue are needed, including 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,” President and CEO Charlie Goodwin said in a news release. “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.”
Renuvion is FDA-cleared to improve the appearance of loose skin on the neck and chin. It is also cleared for specific dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.