FDA 510(k)

ORA Method LED Gua Sha (GS-04)

N.º K: K252272 · 2025-10-09

SolicitanteShenzhen Kaiyan Medical Equipment Co., Ltd.

Fecha de decisión2025-10-09

Código de productoOHS

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

ORA Method LED Gua Sha (GS-04) 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 2025-10-09 under 510(k) number K252272. 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 ORA Method LED Gua Sha (GS-04)?

ORA Method LED Gua Sha (GS-04) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Shenzhen Kaiyan Medical Equipment Co., Ltd.. The 510(k) number is K252272.

When did ORA Method LED Gua Sha (GS-04) receive FDA 510(k) clearance?

ORA Method LED Gua Sha (GS-04) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252272.

Who is the listed applicant for ORA Method LED Gua Sha (GS-04)?

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 ORA Method LED Gua Sha (GS-04)?

The FDA product code for ORA Method LED Gua Sha (GS-04) is OHS.

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Fuente oficial

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