FDA 510(k)

SubNovii Advanced Plasma Technology

Número K: K201738 · 2020-09-10

Data da decisão2020-09-10

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

SubNovii Advanced Plasma Technology is the device name listed in this FDA 510(k) record. The listed applicant is Cartessa Aesthetics. It received FDA 510(k) clearance on 2020-09-10 under 510(k) number K201738. 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 SubNovii Advanced Plasma Technology?

SubNovii Advanced Plasma Technology is a medical device that received FDA 510(k) clearance on 2020-09-10. The listed applicant is Cartessa Aesthetics. The 510(k) number is K201738.

When did SubNovii Advanced Plasma Technology receive FDA 510(k) clearance?

SubNovii Advanced Plasma Technology received FDA 510(k) clearance on 2020-09-10, under 510(k) number K201738.

Who is the listed applicant for SubNovii Advanced Plasma Technology?

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

What is the FDA product code for SubNovii Advanced Plasma Technology?

The FDA product code for SubNovii Advanced Plasma Technology is GEI.

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