FDA 510(k)

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

Número K: K254025 · 2026-06-16

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2026-06-16

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K254025. 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 Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)?

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K254025.

When did LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) receive FDA 510(k) clearance?

LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) received FDA 510(k) clearance on 2026-06-16, under 510(k) number K254025.

Who is the listed applicant for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)?

The FDA 510(k) record lists Shenzhen Kaiyan Medical Equipment Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)?

The FDA product code for LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) is OHS.

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Fonte oficial

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