FDA 510(k)

Wand de Terapia de Luz para Acne

Número K: K160691 · 2016-06-21

Data da decisão2016-06-21

Código do produtoOLP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Acne Light Therapy Wand is the device name listed in this FDA 510(k) record. The listed applicant is Zuko, Inc.. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K160691. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Acne Light Therapy Wand?

Acne Light Therapy Wand is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Zuko, Inc.. The 510(k) number is K160691.

When did Acne Light Therapy Wand receive FDA 510(k) clearance?

Acne Light Therapy Wand received FDA 510(k) clearance on 2016-06-21, under 510(k) number K160691.

Who is the listed applicant for Acne Light Therapy Wand?

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

What is the FDA product code for Acne Light Therapy Wand?

The FDA product code for Acne Light Therapy Wand is OLP.

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