FDA 510(k)

CO2 Laser System (CO2 Laser SST-L23)

Número K: K250183 · 2025-04-24

RequerenteZhuozhou Summer Star Technologies Co., Ltd.

Data da decisão2025-04-24

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CO2 Laser System (CO2 Laser SST-L23) is the device name listed in this FDA 510(k) record. The listed applicant is Zhuozhou Summer Star Technologies Co., Ltd.. It received FDA 510(k) clearance on 2025-04-24 under 510(k) number K250183. 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 System (CO2 Laser SST-L23)?

CO2 Laser System (CO2 Laser SST-L23) is a medical device that received FDA 510(k) clearance on 2025-04-24. The listed applicant is Zhuozhou Summer Star Technologies Co., Ltd.. The 510(k) number is K250183.

When did CO2 Laser System (CO2 Laser SST-L23) receive FDA 510(k) clearance?

CO2 Laser System (CO2 Laser SST-L23) received FDA 510(k) clearance on 2025-04-24, under 510(k) number K250183.

Who is the listed applicant for CO2 Laser System (CO2 Laser SST-L23)?

The FDA 510(k) record lists Zhuozhou Summer Star Technologies Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CO2 Laser System (CO2 Laser SST-L23)?

The FDA product code for CO2 Laser System (CO2 Laser SST-L23) is GEX. This falls under the Gastroenterology category.

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