FDA 510(k)

CO2 Laser Equipment

Número K: K212611 · 2022-02-01

RequerenteBeijing Globalipl Development Co., Ltd.

Data da decisão2022-02-01

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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Fonte oficial

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