FDA 510(k)

CO2 Laser Treatment Machine (CFR3M1)

Número K: K253920 · 2026-03-03

RequerenteHaidari Beauty Technology (Beijing) Co., Ltd.

Data da decisão2026-03-03

Código do produtoGEX

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

CO2 Laser Treatment Machine (CFR3M1) is the device name listed in this FDA 510(k) record. The listed applicant is Haidari Beauty Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253920. 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 Treatment Machine (CFR3M1)?

CO2 Laser Treatment Machine (CFR3M1) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Haidari Beauty Technology (Beijing) Co., Ltd.. The 510(k) number is K253920.

When did CO2 Laser Treatment Machine (CFR3M1) receive FDA 510(k) clearance?

CO2 Laser Treatment Machine (CFR3M1) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253920.

Who is the listed applicant for CO2 Laser Treatment Machine (CFR3M1)?

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

What is the FDA product code for CO2 Laser Treatment Machine (CFR3M1)?

The FDA product code for CO2 Laser Treatment Machine (CFR3M1) is GEX. This falls under the Gastroenterology category.

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