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FDA 510(k)

LED Light Therapy Machine (G1, G3, G4, G6)

N.º K: K242638 · 2024-11-27

SolicitanteShenzhen Walton Technology Co., Ltd.
Fecha de decisión2024-11-27
Código de productoOHS
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Light Therapy Machine (G1, G3, G4, G6) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Walton Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K242638. 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 Machine (G1, G3, G4, G6)?

LED Light Therapy Machine (G1, G3, G4, G6) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Shenzhen Walton Technology Co., Ltd.. The 510(k) number is K242638.

When did LED Light Therapy Machine (G1, G3, G4, G6) receive FDA 510(k) clearance?

LED Light Therapy Machine (G1, G3, G4, G6) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K242638.

Who is the listed applicant for LED Light Therapy Machine (G1, G3, G4, G6)?

The FDA 510(k) record lists Shenzhen Walton 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 Machine (G1, G3, G4, G6)?

The FDA product code for LED Light Therapy Machine (G1, G3, G4, G6) 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.

K260767Facial Beauty Device (Facial Mask LED Beauty Device A-901; Facial LED & EMS Beauty Device A-902; Facial Mask LED & EMS Beauty Device A-907)Kam Yuen Plastic Products , Ltd.K261602Eye Recovery Pro (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)Shenzhen Chuangtong Yigou Technology Co., Ltd.K261851LED Light Therapy Mask (JML1, JML1+JML2); LED Light Therapy Mask (JML3, JML3+JML4); LED Light Therapy Mask (JML5, JML5+JML7); LED Light Therapy Mask (JML6, JML6+JML8); LED Light Therapy Mask ( JML9, JML9+JML10)Shenzhen Qianyu Technology Co., Ltd.K261496LED Light Therapy Masks (PE748, PE749, PE756)Duplex International Trading LimitedK261482LightStim for Wrinkles (1984); LightStim for Acne (2038)Led Intellectual Properties, LLC

Fuente oficial

Ver en la base de datos de la FDA →

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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