Apyx Medical Corporation has submitted a 510(k) premarket notification to the U.S. Food and Drug Administration (FDA) for the AYON Body Contouring System.
The AYON Body Contouring System is an all-in-one platform that integrates Renuvion, ultrasound-assisted liposuction, power-assisted liposuction, infiltration, aspiration, electrocoagulation, and fat transfer into a single device.
The initial submission for AYON includes the following:
- Infiltration
- Dual aspiration
- Ultrasound-assisted liposuction
- Electrocoagulation to support procedures requiring removal of excess tissue
- Volume enhancement capabilities
- Renuvion treatment, which uses a combination of radiofrequency and helium to address loose and lax skin
Later this year, the Company plans to expand the indications with an additional 510(k) submission for AYON to include power-assisted liposuction.
