FDA 510(k)

HIGHERDOSE Red and Infrared Light Mask (MK66-L)

Número K: K241933 · 2024-09-27

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2024-09-27

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

HIGHERDOSE Red and Infrared Light Mask (MK66-L) 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 2024-09-27 under 510(k) number K241933. 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 HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) is a medical device that received FDA 510(k) clearance on 2024-09-27. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K241933.

When did HIGHERDOSE Red and Infrared Light Mask (MK66-L) receive FDA 510(k) clearance?

HIGHERDOSE Red and Infrared Light Mask (MK66-L) received FDA 510(k) clearance on 2024-09-27, under 510(k) number K241933.

Who is the listed applicant for HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

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 HIGHERDOSE Red and Infrared Light Mask (MK66-L)?

The FDA product code for HIGHERDOSE Red and Infrared Light Mask (MK66-L) is OHS.

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Fonte oficial

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