FDA 510(k)

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)

Número K: K243764 · 2025-05-08

RequerenteWuhan Pioon Technology Co., Ltd.

Data da decisão2025-05-08

Código do produtoNVK

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) 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 2025-05-08 under 510(k) number K243764. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)?

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) is a medical device that received FDA 510(k) clearance on 2025-05-08. The listed applicant is Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K243764.

When did Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) receive FDA 510(k) clearance?

Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) received FDA 510(k) clearance on 2025-05-08, under 510(k) number K243764.

Who is the listed applicant for Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)?

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 (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W)?

The FDA product code for Medical Diode Laser (UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W) is NVK.

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Outros registros que listam Wuhan Pioon Technology Co., Ltd. como candidato(a)

K262426Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)K250656Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)K240747Medical Diode Laser (M2-GK)K240644Laser Diodo Médico (S1Pro)K240179Medical Diode Laser (Model: L2)K231548Medical Diode Laser, Model S1Pro

Ver todos os 8 dispositivos →

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Fonte oficial

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