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FDA 510(k)

Diode Laser Therapy Systems (DL612A)

N.º K: K262070 · 2026-08-19

SolicitanteHebei Zollvan Medical Technology Co., Ltd.
Fecha de decisión2026-08-19
Código de productoGEX
Comité asesorSU
DecisiónSubstantially Equivalent

Resumen del dispositivo

Diode Laser Therapy Systems (DL612A) is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Zollvan Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-08-19 under 510(k) number K262070. 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 Diode Laser Therapy Systems (DL612A)?

Diode Laser Therapy Systems (DL612A) is a medical device that received FDA 510(k) clearance on 2026-08-19. The listed applicant is Hebei Zollvan Medical Technology Co., Ltd.. The 510(k) number is K262070.

When did Diode Laser Therapy Systems (DL612A) receive FDA 510(k) clearance?

Diode Laser Therapy Systems (DL612A) received FDA 510(k) clearance on 2026-08-19, under 510(k) number K262070.

Who is the listed applicant for Diode Laser Therapy Systems (DL612A)?

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

What is the FDA product code for Diode Laser Therapy Systems (DL612A)?

The FDA product code for Diode Laser Therapy Systems (DL612A) is GEX. This falls under the Gastroenterology category.

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Dispositivos relacionados (Código: GEX)

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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