FDA 510(k)

LED Facial Mask

Número K: K213056 · 2022-07-07

RequerenteShenzhen Osto Technology Company Limited

Data da decisão2022-07-07

Código do produtoOLP

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Facial Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K213056. 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 LED Facial Mask?

LED Facial Mask is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K213056.

When did LED Facial Mask receive FDA 510(k) clearance?

LED Facial Mask received FDA 510(k) clearance on 2022-07-07, under 510(k) number K213056.

Who is the listed applicant for LED Facial Mask?

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

What is the FDA product code for LED Facial Mask?

The FDA product code for LED Facial Mask is OLP.

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Fonte oficial

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