FDA 510(k)

Renuvion APR Handpiece

N.º K: K220970 · 2022-07-15

SolicitanteApyx Medical Corporation(Formerly Bovie Medical Corporation)

Fecha de decisión2022-07-15

Código de productoGEI

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Renuvion APR Handpiece 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 2022-07-15 under 510(k) number K220970. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the Renuvion APR Handpiece?

Renuvion APR Handpiece is a medical device that received FDA 510(k) clearance on 2022-07-15. The listed applicant is Apyx Medical Corporation(Formerly Bovie Medical Corporation). The 510(k) number is K220970.

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

Renuvion APR Handpiece received FDA 510(k) clearance on 2022-07-15, under 510(k) number K220970.

Who is the listed applicant for Renuvion APR Handpiece?

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 APR Handpiece?

The FDA product code for Renuvion APR Handpiece is GEI.

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Otros registros que enlistan a Apyx Medical Corporation(Formerly Bovie Medical Corporation) como solicitante

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Fuente oficial

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