FDA 510(k)

Renuvion/J-Plasma Precise Handpiece

Número K: K191484 · 2019-07-30

RequerenteApyx Medical Corporation(Formerly Bovie Medical Corporation)

Data da decisão2019-07-30

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Renuvion/J-Plasma Precise 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 2019-07-30 under 510(k) number K191484. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Renuvion/J-Plasma Precise Handpiece?

Renuvion/J-Plasma Precise Handpiece is a medical device that received FDA 510(k) clearance on 2019-07-30. The listed applicant is Apyx Medical Corporation(Formerly Bovie Medical Corporation). The 510(k) number is K191484.

When did Renuvion/J-Plasma Precise Handpiece receive FDA 510(k) clearance?

Renuvion/J-Plasma Precise Handpiece received FDA 510(k) clearance on 2019-07-30, under 510(k) number K191484.

Who is the listed applicant for Renuvion/J-Plasma Precise 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/J-Plasma Precise Handpiece?

The FDA product code for Renuvion/J-Plasma Precise Handpiece is GEI.

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Outros registros que listam Apyx Medical Corporation(Formerly Bovie Medical Corporation) como candidato(a)

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Fonte oficial

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