USFDAMay 11, 2026, 08:11 AM
Apyx Medical Receives Expanded FDA Clearance for AYON System
AI Summary
Apyx Medical Corporation announced it received expanded 510(k) clearance from the U.S. Food and Drug Administration for its AYON Body Contouring System. This clearance now includes power liposuction, an advanced modality designed to enhance the efficiency of fat removal and reduce surgeon effort. The company anticipates this addition will significantly increase market demand for the AYON system and plans a limited commercial launch to refine training and customer experience.
Key Highlights
- Apyx Medical received expanded FDA 510(k) clearance for its AYON Body Contouring System.
- The clearance adds power liposuction capability to the AYON system.
- Power liposuction uses a reciprocating cannula to enhance fat removal efficiency.
- The company expects the addition to drive greater market demand for AYON.
- A limited commercial launch of the power liposuction function is planned.
- The system now integrates fat removal, closed loop contouring, and Renuvion capabilities.