AYON Body Contouring System (AYON SYSTEM)— 510(k) K253396

Name: FDA 510(k) clearance K253396
Creator: U.S. Food and Drug Administration
Published: 2026-05-08

Substantially Equivalent

Apyx Medical Corporation

FDA 510(k) clearance K253396 for AYON Body Contouring System (AYON SYSTEM), Substantially Equivalent on 2026-05-08. 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: 2025-09-30
Decision date: 2026-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clearwater, FL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QPB

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K254135 — LipoSurg ARTIST2026-09-05
K261710 — AYON Power Liposuction Cannulas and AYON Power Liposuction Cannula Adaptors2026-08-21
K251944 — Lipocosm Harmonic System2026-06-08
K252495 — LSSA (NP-200)2026-04-03
K244050 — AYON Body Contouring System (AYON SYSTEM)2025-05-12

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