FDA 510(k)

CO2 激光设备

K号: K212611 · 2022-02-01

申请人Beijing Globalipl Development Co., Ltd.

决定日期2022-02-01

产品代码GEX

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决定实质等同

器械摘要

CO2 Laser Equipment is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Globalipl Development Co., Ltd.. It received FDA 510(k) clearance on 2022-02-01 under 510(k) number K212611. 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 CO2 Laser Equipment?

CO2 Laser Equipment is a medical device that received FDA 510(k) clearance on 2022-02-01. The listed applicant is Beijing Globalipl Development Co., Ltd.. The 510(k) number is K212611.

When did CO2 Laser Equipment receive FDA 510(k) clearance?

CO2 Laser Equipment received FDA 510(k) clearance on 2022-02-01, under 510(k) number K212611.

Who is the listed applicant for CO2 Laser Equipment?

The FDA 510(k) record lists Beijing Globalipl Development Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser Equipment?

The FDA product code for CO2 Laser Equipment is GEX. This falls under the Gastroenterology category.

列明Beijing Globalipl Development 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。

K222916美国 450 二极管激光设备 K220385强脉冲光设备 K193328IPL + 二极管激光机

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