FDA 510(k)

Renuvion Dermal Handpiece, Renuvion Dermal System

Numéro K : K211652 · 2022-05-25

DemandeurApyx Medical Corporation (Formerly Bovie Medical Corporation

Date de décision2022-05-25

Code produitGEI

Comité consultatifSU

DécisionSubstantially Equivalent

Résumé du dispositif

Renuvion Dermal Handpiece, Renuvion Dermal System is the device name listed in this FDA 510(k) record. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. It received FDA 510(k) clearance on 2022-05-25 under 510(k) number K211652. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the Renuvion Dermal Handpiece, Renuvion Dermal System?

Renuvion Dermal Handpiece, Renuvion Dermal System is a medical device that received FDA 510(k) clearance on 2022-05-25. The listed applicant is Apyx Medical Corporation (Formerly Bovie Medical Corporation. The 510(k) number is K211652.

When did Renuvion Dermal Handpiece, Renuvion Dermal System receive FDA 510(k) clearance?

Renuvion Dermal Handpiece, Renuvion Dermal System received FDA 510(k) clearance on 2022-05-25, under 510(k) number K211652.

Who is the listed applicant for Renuvion Dermal Handpiece, Renuvion Dermal System?

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

What is the FDA product code for Renuvion Dermal Handpiece, Renuvion Dermal System?

The FDA product code for Renuvion Dermal Handpiece, Renuvion Dermal System is GEI.

Essais cliniques associés

Les enregistrements connexes sont mis en correspondance automatiquement à l'aide des noms, codes produits ou autres métadonnées. Une mise en correspondance n'établit pas de relation clinique, scientifique, corporative ou réglementaire vérifiée ; veuillez consulter les sources officielles liées.

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Autres dossiers indiquant Apyx Medical Corporation (Formerly Bovie Medical Corporation en tant que demandeur

K220970Renuvion APR Handpiece K202880J-Plasma Precise FLEX Handpiece K191484Renuvion/J-Plasma Precise Handpiece

Dispositifs connexes (Code : GEI)

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Source officielle

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