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.

Summary

Apyx Medical's AYON Body Contouring System (AYON SYSTEM) is filed under QPB, suction lipoplasty systems for removal.

Class II, 21 CFR 878.5040. General and Plastic Surgery is both the classification panel and the review panel. The submission was a Traditional 510(k).

Apyx filed from Clearwater, Florida. Review took 220 calendar days (September 30, 2025 to May 8, 2026).

Clearance details

Applicant: Apyx Medical Corporation
Product code: Product 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

view all

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

More clearances from Apyx Medical Corporation

view all

K230586 — Renuvion® Micro Handpiece2023-06-09
K230272 — Renuvion® APR Handpiece2023-04-27
K223262 — Renuvion® APR Handpiece2023-02-23
K221830 — Apyx One Console2022-10-11

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