FDA 510(k)

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert

Número K: K162231 · 2016-11-16

Data da decisão2016-11-16

Código do produtoOHT

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert is the device name listed in this FDA 510(k) record. The listed applicant is Cyden Limited. It received FDA 510(k) clearance on 2016-11-16 under 510(k) number K162231. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert?

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert is a medical device that received FDA 510(k) clearance on 2016-11-16. The listed applicant is Cyden Limited. The 510(k) number is K162231.

When did iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert receive FDA 510(k) clearance?

iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert received FDA 510(k) clearance on 2016-11-16, under 510(k) number K162231.

Who is the listed applicant for iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert?

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

What is the FDA product code for iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert?

The FDA product code for iPulse SmoothSkin Gold Hair Removal Device, Venus Silk.expert is OHT.

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Dispositivos Relacionados (Código: OHT)

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Fonte oficial

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