USFDAMay 11, 2026, 08:01 AM
Apyx Medical gets FDA 510(k) for AYON power liposuction
AI Summary
Apyx Medical Corporation announced it received expanded 510(k) clearance from the U.S. FDA for its AYON Body Contouring System to include power liposuction. This advanced function uses a reciprocating cannula to improve fat removal efficiency, reducing surgeon effort and operating room time. The company plans a limited commercial launch of the power liposuction function, aiming to refine training and customer experience before broader adoption, and believes this integration makes AYON the gold-standard in surgical aesthetics.
Key Highlights
- Apyx Medical received expanded 510(k) clearance from the FDA for its AYON Body Contouring System.
- The clearance includes power liposuction, an advanced form of liposuction.
- Power liposuction uses a reciprocating cannula to enhance fat removal efficiency.
- The company believes AYON with power liposuction is the gold-standard system in surgical aesthetics.
- A limited commercial launch of the power liposuction function is planned.
- The AYON system integrates fat removal, closed loop contouring, and Renuvion capabilities.
- Apyx Medical filed the 510(k) for label expansion in October 2025.
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