The U.S. Food and Drug Administration (FDA) has cleared Apyx Medical’s AYON Body Contouring System.
This initial 510(k) clearance covers a wide variety of aesthetic treatments, including Renuvion to address loose and lax skin, ultrasound-assisted liposuction, electrocoagulation to support procedures requiring removal of excess tissue, along with several others. The Company is actively preparing for a commercial launch of AYON with key surgeons in critical geographies starting in the second half of 2025. The Company plans to expand the cleared indications for AYON, to include power liposuction, with an additional 510(k) submission later this year.
AYON integrates fat removal, closed loop contouring, tissue contraction, and electrosurgical capabilities for body contouring treatments. The system includes LIFT Technology for real-time adjustments and Renuvion for enhanced tissue contraction. Apyx Medical’s Renuvion is a minimally invasive procedure that uses a combination of radiofrequency and helium to tighten loose skin, often in conjunction with liposuction or other surgical contouring procedures.
“Receiving FDA clearance for the AYON Body Contouring System, which includes our proprietary Renuvion technology for the treatment of loose and lax skin, marks a major step forward in our mission to empower surgeons with transformative tools. By uniting multiple technologies into one powerful platform, AYON is designed to streamline procedures, elevate surgical precision, and ultimately deliver better outcomes for patients,” says Charlie Goodwin, President and CEO of Apyx Medical Corporation, in a news release. “The aesthetics market is expecting a rapid increase in body contouring procedures over the course of the next year, as the more than 15 million patients currently using GLP-1 drugs achieve rapid weight loss and seek solutions for addressing their loose and lax skin and reshaping their new bodies. AYON provides surgeons with all the necessary solutions in one device for meeting the needs of these patients.”
