FDA 510(k)

Renuvion® APR Handpiece

K-Number: K230272 · 2023-04-27

Decision Date2023-04-27

Product CodeGEI

Advisory CommitteeSU

DecisionSubstantially Equivalent

Device Summary

Renuvion® APR Handpiece is a medical device manufactured by Apyx Medical Corporation. It received FDA 510(k) clearance on 2023-04-27 under approval number K230272. 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 2023-04-27. It is manufactured by Apyx Medical Corporation. The 510(k) number is K230272.

When was Renuvion® APR Handpiece approved by the FDA?

Renuvion® APR Handpiece received FDA 510(k) clearance on 2023-04-27, under approval number K230272.

What company makes Renuvion® APR Handpiece?

Renuvion® APR Handpiece is manufactured by Apyx Medical Corporation.

What is the FDA product code for Renuvion® APR Handpiece?

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

Other Devices by Apyx Medical Corporation

K221830Apyx One Console K230586Renuvion® Micro Handpiece K223262Renuvion® APR Handpiece K244050AYON Body Contouring System (AYON SYSTEM) K253396AYON Body Contouring System (AYON SYSTEM)

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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.