regulatory
confidence high
sentiment positive
materiality 0.60
Apyx Medical receives FDA 510(k) clearance for AYON Body Contouring System
Apyx Medical Corp
- AYON is the first FDA-cleared all-in-one platform combining fat removal, contouring, tissue contraction, and electrosurgery.
- Initial clearance covers Renuvion for lax skin, ultrasound liposuction, electrocoagulation; power liposuction submission planned later in 2025.
- Commercial launch with key opinion leader surgeons in critical geographies expected in second half of 2025.
- Company highlights >15 million GLP-1 drug users as a growth driver for body contouring procedures.