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FDA 510(k)

Renuvion® APR Handpiece

K-Number: K223262 · 2023-02-23

ApplicantApyx Medical Corporation
Decision Date2023-02-23
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renuvion® APR Handpiece 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 2023-02-23 under 510(k) number K223262. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Renuvion® APR Handpiece?

Renuvion® APR Handpiece is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Apyx Medical Corporation. The 510(k) number is K223262.

When did Renuvion® APR Handpiece receive FDA 510(k) clearance?

Renuvion® APR Handpiece received FDA 510(k) clearance on 2023-02-23, under 510(k) number K223262.

Who is the listed applicant for Renuvion® APR Handpiece?

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 Renuvion® APR Handpiece?

The FDA product code for Renuvion® APR Handpiece is GEI.

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.

K253396AYON Body Contouring System™ (AYON SYSTEM)K244050AYON Body Contouring System (AYON SYSTEM)K230586Renuvion® Micro HandpieceK230272Renuvion® APR HandpieceK221830Apyx One Console

Related Devices (Code: GEI)

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.

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Official Source

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

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