FDA 510(k)

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

N.º K: K262426 · 2026-09-10

SolicitanteWuhan Pioon Technology Co., Ltd.

Fecha de decisión2026-09-10

Código de productoGEX

Comité asesorSU

DecisiónSubstantially Equivalent

Resumen del dispositivo

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) 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 2026-09-10 under 510(k) number K262426. 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 (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)?

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) is a medical device that received FDA 510(k) clearance on 2026-09-10. The listed applicant is Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K262426.

When did Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) receive FDA 510(k) clearance?

Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) received FDA 510(k) clearance on 2026-09-10, under 510(k) number K262426.

Who is the listed applicant for Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)?

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 (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)?

The FDA product code for Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) is GEX. This falls under the Gastroenterology category.

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

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)K231548Medical Diode Laser, Model S1Pro

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Fuente oficial

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