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8-K2026-05-11· grok-4-1-fast-non-reasoning

APYX · Apyx Medical Corporation

0001437749-26-016000

SEC filing

Summary

Apyx Medical Corporation received expanded FDA 510(k) clearance for its AYON Body Contouring System to include power liposuction capability.

Key takeaways

Full analysis

Apyx Medical Corporation announced expanded 510(k) clearance for its AYON Body Contouring System, adding power liposuction as a second advanced liposuction modality. This enhancement uses a reciprocating cannula to improve efficiency in fat removal, reducing surgeon effort and operating room time. CEO Charlie Goodwin stated that AYON is now the gold-standard system in surgical aesthetics, enabling multiple body contouring modalities in a unified platform to streamline workflows and support patient outcomes. The company filed for this label expansion in October 2025 and plans a limited commercial launch to work with early adopters on training and utilization before broader rollout, positioning AYON to capture increased market demand in the surgical aesthetics sector.