FDA 510(k)

Q-Switched Nd:Yag laser

K号: K232716 · 2023-11-30

决定日期2023-11-30

产品代码GEX

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决定实质等同

器械摘要

Q-Switched Nd:Yag laser is the device name listed in this FDA 510(k) record. The listed applicant is Hebei Zhemai Technology Co., Ltd.. It received FDA 510(k) clearance on 2023-11-30 under 510(k) number K232716. 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 Q-Switched Nd:Yag laser?

Q-Switched Nd:Yag laser is a medical device that received FDA 510(k) clearance on 2023-11-30. The listed applicant is Hebei Zhemai Technology Co., Ltd.. The 510(k) number is K232716.

When did Q-Switched Nd:Yag laser receive FDA 510(k) clearance?

Q-Switched Nd:Yag laser received FDA 510(k) clearance on 2023-11-30, under 510(k) number K232716.

Who is the listed applicant for Q-Switched Nd:Yag laser?

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

What is the FDA product code for Q-Switched Nd:Yag laser?

The FDA product code for Q-Switched Nd:Yag laser is GEX. This falls under the Gastroenterology category.

列明Hebei Zhemai Technology Co., Ltd.为申报人的其他记录

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