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FDA 510(k)

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)

N.º K: K253400 · 2025-12-24

SolicitanteShenzhen Saidi Light Therapy Technology Co., Ltd.
Fecha de decisión2025-12-24
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Saidi Light Therapy Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-12-24 under 510(k) number K253400. 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 Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)?

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) is a medical device that received FDA 510(k) clearance on 2025-12-24. The listed applicant is Shenzhen Saidi Light Therapy Technology Co., Ltd.. The 510(k) number is K253400.

When did LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) receive FDA 510(k) clearance?

LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) received FDA 510(k) clearance on 2025-12-24, under 510(k) number K253400.

Who is the listed applicant for LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)?

The FDA 510(k) record lists Shenzhen Saidi Light Therapy 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 Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)?

The FDA product code for LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W) is OHS.

Ensayos clínicos relacionados

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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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