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FDA 510(k)

Renuvion® Micro Handpiece

K-Number: K230586 · 2023-06-09

ApplicantApyx Medical Corporation
Decision Date2023-06-09
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Renuvion® Micro 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 2023-06-09 under 510(k) number K230586. 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® Micro Handpiece?

Renuvion® Micro Handpiece is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Apyx Medical Corporation. The 510(k) number is K230586.

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

Renuvion® Micro Handpiece received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230586.

Who is the listed applicant for Renuvion® Micro 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® Micro Handpiece?

The FDA product code for Renuvion® Micro 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.

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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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