FDA 510(k)

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)

N.º K: K250966 · 2025-06-25

SolicitanteShenzhen Kaiyan Medical Equipment Co., Ltd.

Fecha de decisión2025-06-25

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) 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 2025-06-25 under 510(k) number K250966. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)?

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) is a medical device that received FDA 510(k) clearance on 2025-06-25. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K250966.

When did CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) receive FDA 510(k) clearance?

CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) received FDA 510(k) clearance on 2025-06-25, under 510(k) number K250966.

Who is the listed applicant for CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)?

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 Skin™ LED Light Therapy Mask Series 2 (MK-90H)?

The FDA product code for CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H) is OHS.

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Fuente oficial

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