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FDA 510(k)

AYON Body Contouring System™ (AYON SYSTEM)

K-Number: K253396 · 2026-05-08

ApplicantApyx Medical Corporation
Decision Date2026-05-08
Product CodeQPB
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

AYON Body Contouring System™ (AYON SYSTEM) is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K253396. The device is classified under product code QPB. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AYON Body Contouring System™ (AYON SYSTEM)?

AYON Body Contouring System™ (AYON SYSTEM) is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is Apyx Medical Corporation. The 510(k) number is K253396.

When did AYON Body Contouring System™ (AYON SYSTEM) receive FDA 510(k) clearance?

AYON Body Contouring System™ (AYON SYSTEM) received FDA 510(k) clearance on 2026-05-08, under 510(k) number K253396.

Who is the listed applicant for AYON Body Contouring System™ (AYON SYSTEM)?

The FDA 510(k) record lists Apyx Medical Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AYON Body Contouring System™ (AYON SYSTEM)?

The FDA product code for AYON Body Contouring System™ (AYON SYSTEM) is QPB.

Other records listing Apyx Medical Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K244050AYON Body Contouring System (AYON SYSTEM)K230586Renuvion® Micro HandpieceK230272Renuvion® APR HandpieceK223262Renuvion® APR HandpieceK221830Apyx One Console

Related Devices (Code: QPB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K251944Lipocosm Harmonic SystemLipocosm, LLCK252495LSSA (NP-200)Newpong Co., Ltd.K244050AYON Body Contouring System (AYON SYSTEM)Apyx Medical CorporationK244026PAL 7020 ConsoleMicroaire Surgical Instruments, LLCK242804PAL Aspiration SystemMicroaire Surgical Instruments, LLCK241835AirSculpt Body Contouring System (AIRS-1-SYS)Cellmyx

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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