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FDA 510(k)

CO2 Laser Treatment Machine (CFR3M1)

K-Number: K253920 · 2026-03-03

ApplicantHaidari Beauty Technology (Beijing) Co., Ltd.
Decision Date2026-03-03
Product CodeGEX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CO2 Laser Treatment Machine (CFR3M1) is a medical device manufactured by Haidari Beauty Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under approval 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.

Frequently Asked Questions

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. It is manufactured by Haidari Beauty Technology (Beijing) Co., Ltd.. The 510(k) number is K253920.

When was CO2 Laser Treatment Machine (CFR3M1) approved by the FDA?

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

What company makes CO2 Laser Treatment Machine (CFR3M1)?

CO2 Laser Treatment Machine (CFR3M1) is manufactured by Haidari Beauty Technology (Beijing) Co., Ltd..

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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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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