FDA 510(k)

Plasma Pen (Plasma MD); Plasma Pen (Plasma +)

Número K: K223440 · 2023-03-02

Data da decisão2023-03-02

Código do produtoQVJ

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is the device name listed in this FDA 510(k) record. The listed applicant is Plasma Concepts. It received FDA 510(k) clearance on 2023-03-02 under 510(k) number K223440. The device is classified under product code QVJ. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?

Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is a medical device that received FDA 510(k) clearance on 2023-03-02. The listed applicant is Plasma Concepts. The 510(k) number is K223440.

When did Plasma Pen (Plasma MD); Plasma Pen (Plasma +) receive FDA 510(k) clearance?

Plasma Pen (Plasma MD); Plasma Pen (Plasma +) received FDA 510(k) clearance on 2023-03-02, under 510(k) number K223440.

Who is the listed applicant for Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?

The FDA 510(k) record lists Plasma Concepts as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Plasma Pen (Plasma MD); Plasma Pen (Plasma +)?

The FDA product code for Plasma Pen (Plasma MD); Plasma Pen (Plasma +) is QVJ.

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Dispositivos Relacionados (Código: QVJ)

K233760Mjolnir Pro. (Multi–electrode plasma)Shenzhen Leaflife Technology Co., Ltd.K220493Plaxpot Multi PlasmaGcs Co. Limited K213247JETT PLASMA Medical IICompex, Spol, S.R.O.

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