FDA 510(k)

Project E Beauty LED Light Therapy Mask (Model: PE730)

Número K: K214101 · 2022-03-23

RequerenteDuplex International Trading Limited

Data da decisão2022-03-23

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Project E Beauty LED Light Therapy Mask (Model: PE730) is the device name listed in this FDA 510(k) record. The listed applicant is Duplex International Trading Limited. It received FDA 510(k) clearance on 2022-03-23 under 510(k) number K214101. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Project E Beauty LED Light Therapy Mask (Model: PE730)?

Project E Beauty LED Light Therapy Mask (Model: PE730) is a medical device that received FDA 510(k) clearance on 2022-03-23. The listed applicant is Duplex International Trading Limited. The 510(k) number is K214101.

When did Project E Beauty LED Light Therapy Mask (Model: PE730) receive FDA 510(k) clearance?

Project E Beauty LED Light Therapy Mask (Model: PE730) received FDA 510(k) clearance on 2022-03-23, under 510(k) number K214101.

Who is the listed applicant for Project E Beauty LED Light Therapy Mask (Model: PE730)?

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

What is the FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730)?

The FDA product code for Project E Beauty LED Light Therapy Mask (Model: PE730) is OHS.

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Outros registros que listam Duplex International Trading Limited como candidato(a)

K261496LED Light Therapy Masks (PE748, PE749, PE756)

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Fonte oficial

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