FDA 510(k)

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)

Número K: K242593 · 2025-02-14

RequerenteShenzhen Kaiyan Medical Equipment Co., Ltd.

Data da decisão2025-02-14

Código do produtoOHS

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) 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 2025-02-14 under 510(k) number K242593. 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 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)?

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) is a medical device that received FDA 510(k) clearance on 2025-02-14. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K242593.

When did CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) receive FDA 510(k) clearance?

CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) received FDA 510(k) clearance on 2025-02-14, under 510(k) number K242593.

Who is the listed applicant for CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)?

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 CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)?

The FDA product code for CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N) is OHS.

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Fonte oficial

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