FDA 510(k)

LED Light Therapy Masks (PE748, PE749, PE756)

Número K: K261496 · 2026-08-04

RequerenteDuplex International Trading Limited

Data da decisão2026-08-04

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Light Therapy Masks (PE748, PE749, PE756) 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 2026-08-04 under 510(k) number K261496. 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 LED Light Therapy Masks (PE748, PE749, PE756)?

LED Light Therapy Masks (PE748, PE749, PE756) is a medical device that received FDA 510(k) clearance on 2026-08-04. The listed applicant is Duplex International Trading Limited. The 510(k) number is K261496.

When did LED Light Therapy Masks (PE748, PE749, PE756) receive FDA 510(k) clearance?

LED Light Therapy Masks (PE748, PE749, PE756) received FDA 510(k) clearance on 2026-08-04, under 510(k) number K261496.

Who is the listed applicant for LED Light Therapy Masks (PE748, PE749, PE756)?

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 LED Light Therapy Masks (PE748, PE749, PE756)?

The FDA product code for LED Light Therapy Masks (PE748, PE749, PE756) is OHS.

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

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Fonte oficial

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