FDA 510(k)

医疗二极管激光器（型号：MZ-GK, MZ-K20, MZ-N75）

K号: K250656 · 2025-04-04

决定日期2025-04-04

产品代码GEX

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决定实质等同

器械摘要

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-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 2025-04-04 under 510(k) number K250656. 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.

常见问题

What is the Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)?

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is a medical device that received FDA 510(k) clearance on 2025-04-04. The listed applicant is Wuhan Pioon Technology Co., Ltd.. The 510(k) number is K250656.

When did Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) receive FDA 510(k) clearance?

Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) received FDA 510(k) clearance on 2025-04-04, under 510(k) number K250656.

Who is the listed applicant for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)?

FDA 510(k)记录将武汉派奥科技有限公司列为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)?

The FDA product code for Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) is GEX. This falls under the Gastroenterology category.

列明Wuhan Pioon Technology Co., Ltd.为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262426医疗二极管激光器（S1Pro+，S1Pro K15，S1Pro N6，S1Pro N75）K243764医疗二极管激光器（UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W）K240747医疗二极管激光器（M2-GK）K240644医疗二极管激光器（S1Pro）K240179医疗二极管激光器（型号：L2）K231548医疗二极管激光，型号S1Pro

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官方来源

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