FDA 510(k)

Medical Diode Laser, Model S1Pro

N.º K: K231548 · 2023-08-03

SolicitanteWuhan Pioon Technology Co., Ltd.

Fecha de decisión2023-08-03

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Diode Laser, Model S1Pro is the device name listed in this FDA 510(k) record. The listed applicant is Wuhan Pioon Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-08-03 under 510(k) number K231548. 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 Medical Diode Laser, Model S1Pro?

Medical Diode Laser, Model S1Pro is a medical device that received FDA 510(k) clearance on 2023-08-03. The listed applicant is Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K231548.

When did Medical Diode Laser, Model S1Pro receive FDA 510(k) clearance?

Medical Diode Laser, Model S1Pro received FDA 510(k) clearance on 2023-08-03, under 510(k) number K231548.

Who is the listed applicant for Medical Diode Laser, Model S1Pro?

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

What is the FDA product code for Medical Diode Laser, Model S1Pro?

The FDA product code for Medical Diode Laser, Model S1Pro is GEX. This falls under the Gastroenterology category.

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Otros registros que enlistan a Wuhan Pioon Technology Co., Ltd. como solicitante

K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)K243764Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)K240747Medical Diode Laser (M2-GK)K240644Láser Diódico Médico (S1Pro)K240179Medical Diode Laser (Model: L2)

Ver todos los 8 dispositivos →

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Fuente oficial

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