Apyx Secures FDA Clearance for AYON System Power Liposuction Feature
Apyx Medical received FDA 510(k) clearance to add advanced power liposuction capability using a reciprocating cannula to its AYON Body Contouring System, improving fat‐removal efficiency and reducing operating room time. The company will initiate a limited commercial launch with early adopters to refine training and customer experience before wider rollout.
1. FDA Clearance Expansion
The FDA granted Apyx Medical an expanded 510(k) clearance for the AYON Body Contouring System to include power liposuction, enabling surgeons to use a reciprocating cannula for more efficient fat removal. This approval positions AYON as a multi‐modality platform combining liposuction with existing Renuvion tissue contraction.
2. Limited Commercial Launch
Apyx plans a phased rollout, starting with a limited commercial launch to collaborate with early adopters. This approach will allow the company to refine training protocols, optimize utilization, and enhance the overall customer experience prior to scaling deliveries.
3. Unified System Advantages
By integrating power liposuction into AYON’s all-in-one platform, surgeons can perform fat removal, closed-loop contouring, and electrosurgical tissue contraction without switching devices. This streamlined workflow aims to lower operating room time, reduce surgeon effort, and support superior patient outcomes.