The platform integrates fat removal, closed-loop contouring, tissue contraction, and electrosurgical capabilities.
Apyx Medical Corporation, the manufacturer of a helium plasma and radiofrequency technology marketed and sold as Renuvion, has received 510(k) clearance from the US Food and Drug Administration for the AYON Body Contouring System. The company is preparing for a commercial launch of AYON with key surgeons in critical geographies starting in the second half of 2025.
AYON is a surgeon-designed body contouring system that integrates fat removal, closed-loop contouring, tissue contraction, and electrosurgical capabilities. The system includes features like LIFT Technology for real-time adjustments and Renuvion for enhanced tissue contraction.
This initial 510(k) clearance for AYON covers a 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 plans to expand the cleared indications for AYON to include power liposuction, with an additional 510(k) submission later this year.
“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 release.
Goodwin notes that the aesthetics market is anticipating a rise in body contouring procedures over the next year, as more than 15 million GLP-1 drug users experience rapid weight loss and seek solutions for loose skin and reshaping their bodies.
“AYON provides surgeons with all the necessary solutions in one device for meeting the needs of these patients,” says Goodwin in a release.
Photo caption: AYON Body Contouring System
Photo credit: Apyx Medical Corporation
