FDA 510(k)

医疗二极管激光器（UTU3-F7B,UTU3-F7W,UTU3-G7B,UTU3-G7W,UTU-G20B,UTU-G20W）

K号: K243764 · 2025-05-08

决定日期2025-05-08

产品代码NVK

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决定实质等同

器械摘要

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.

常见问题

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)?

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 (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.

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）K250656医疗二极管激光器（型号：MZ-GK, MZ-K20, MZ-N75）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

查看所有 8 个设备 →

相关器械（代码：NVK）

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。

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官方来源

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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。