FDAnews
www.fdanews.com/articles/211367-apyx-medical-handpiece-device-gets-expanded-clearance-for-soft-tissue

Apyx Medical Handpiece Device Gets Expanded Clearance for Soft Tissue

March 6, 2023

The FDA has granted 510(k) marketing clearance to Apyx Medical’s Renuvion APR handpiece for use on soft tissue, including subcutaneous, to improve the appearance of loose skin.

The clearance is for “the delivery of radiofrequency energy and/or helium plasma where coagulation/contraction of soft tissue is needed,” the FDA said, by delivering controlled heat to tissue.

The device is also indicated for subcutaneous dermatological and aesthetic procedures to improve the appearance of loose skin in the neck and under the chin.

The product is also under FDA review for contraction of subcutaneous soft tissues following liposuction.

View today's stories