AYON Body Contouring System (AYON SYSTEM)— 510(k) K244050

Name: FDA 510(k) clearance K244050
Creator: U.S. Food and Drug Administration
Published: 2025-05-12

Substantially Equivalent

Apyx Medical Corporation

FDA 510(k) clearance K244050 for AYON Body Contouring System (AYON SYSTEM), Substantially Equivalent on 2025-05-12. Applicant: Apyx Medical Corporation. Device class: 2.

Clearance details

Applicant: Apyx Medical Corporation
Product code: Code QPB
Device class: Class 2
Regulation: 21 CFR 878.5040
Advisory panel: General, Plastic Surgery
Date received: 2024-12-31
Decision date: 2025-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

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K253396 — AYON Body Contouring System (AYON SYSTEM)2026-05-08
K252495 — LSSA (NP-200)2026-04-03

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Data sourced from openFDA. This site is unofficial and independent of the FDA.