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FDA 510(k)

LED Light Therapy Mask (2311, 2344, 2457, 2458)

N.º K: K252189 · 2025-09-12

SolicitanteDongguan Yanxi Technology Co., Ltd.
Fecha de decisión2025-09-12
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Mask (2311, 2344, 2457, 2458) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Yanxi Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-09-12 under 510(k) number K252189. 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 LED Light Therapy Mask (2311, 2344, 2457, 2458)?

LED Light Therapy Mask (2311, 2344, 2457, 2458) is a medical device that received FDA 510(k) clearance on 2025-09-12. The listed applicant is Dongguan Yanxi Technology Co., Ltd.. The 510(k) number is K252189.

When did LED Light Therapy Mask (2311, 2344, 2457, 2458) receive FDA 510(k) clearance?

LED Light Therapy Mask (2311, 2344, 2457, 2458) received FDA 510(k) clearance on 2025-09-12, under 510(k) number K252189.

Who is the listed applicant for LED Light Therapy Mask (2311, 2344, 2457, 2458)?

The FDA 510(k) record lists Dongguan Yanxi Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Mask (2311, 2344, 2457, 2458)?

The FDA product code for LED Light Therapy Mask (2311, 2344, 2457, 2458) is OHS.

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Dispositivos relacionados (Código: OHS)

Los registros relacionados se emparejan automáticamente mediante nombres, códigos de producto u otros metadatos. Un emparejamiento no establece una relación clínica, científica, corporativa o regulatoria verificada; revise las fuentes oficiales enlazadas.

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Fuente oficial

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Datos procedentes de la API abierta de la FDA. Para obtener la información más actualizada y autoritativa, consulte siempre el registro oficial.

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