FDA 510(k)

NutraStim Hair Laser Helmet

Número K: K160728 · 2016-09-16

Data da decisão2016-09-16

Código do produtoOAP

Comité consultivoPM

DecisãoSubstantially Equivalent

Resumo do dispositivo

NutraStim Hair Laser Helmet is the device name listed in this FDA 510(k) record. The listed applicant is Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K160728. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the NutraStim Hair Laser Helmet?

NutraStim Hair Laser Helmet is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Nutra Luxe MD, LLC. The 510(k) number is K160728.

When did NutraStim Hair Laser Helmet receive FDA 510(k) clearance?

NutraStim Hair Laser Helmet received FDA 510(k) clearance on 2016-09-16, under 510(k) number K160728.

Who is the listed applicant for NutraStim Hair Laser Helmet?

The FDA 510(k) record lists Nutra Luxe MD, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NutraStim Hair Laser Helmet?

The FDA product code for NutraStim Hair Laser Helmet is OAP.

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Dispositivos Relacionados (Código: OAP)

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Fonte oficial

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