FDA 510(k)

LED Therapy Device (Planar LED/Planar LED mini)

N.º K: K220103 · 2022-04-12

SolicitanteShenzhen Leaflife Technology Co., Ltd.

Fecha de decisión2022-04-12

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

LED Therapy Device (Planar LED/Planar LED mini) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. It received FDA 510(k) clearance on 2022-04-12 under 510(k) number K220103. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Preguntas frecuentes

What is the LED Therapy Device (Planar LED/Planar LED mini)?

LED Therapy Device (Planar LED/Planar LED mini) is a medical device that received FDA 510(k) clearance on 2022-04-12. The listed applicant is Shenzhen Leaflife Technology Co., Ltd.. The 510(k) number is K220103.

When did LED Therapy Device (Planar LED/Planar LED mini) receive FDA 510(k) clearance?

LED Therapy Device (Planar LED/Planar LED mini) received FDA 510(k) clearance on 2022-04-12, under 510(k) number K220103.

Who is the listed applicant for LED Therapy Device (Planar LED/Planar LED mini)?

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

What is the FDA product code for LED Therapy Device (Planar LED/Planar LED mini)?

The FDA product code for LED Therapy Device (Planar LED/Planar LED mini) is GEX. This falls under the Gastroenterology category.

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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.