Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 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.

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. 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.

Related Devices (Code: GEX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261841Q Switched Nd:YAG Laser machine (QLQW-01)Beijing Nubway S&T Co., Ltd.K261221SOLTIVE™ Laser System (SOLTIVE™ Pro SuperPulsed Laser, SOLTIVE™ Premium SuperPulsed Laser, SOLTIVE Laser Fibers, and Accessories)Olympus Surgical Technologies AmericaK261738Medical Thulium Fiber Laser Systems (UroFiber 150Q)Rhein Laser Technologies Co., Ltd.K261693Diode laser hair removal machine (QDTM-04)Beijing Nubway S&T Co., Ltd.K261674Skin Air Cooling System (QALF-01)Beijing Nubway S&T Co., Ltd.K261701Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)Micro-Energy Medical Technology Co., Ltd.

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.

↑