K-number	K253920
Device name	CO2 Laser Treatment Machine (CFR3M1)
Applicant	Haidari Beauty Technology (Beijing) Co., Ltd.
Product code	GEX
Device class	Class II
Decision date	Mar 3, 2026
Decision	Substantially Equivalent
Regulation	878.4810

AI Summary extracted from FDA summary PDF · never regenerated

Intended use

The CO2 Laser Treatment Machine (CFR3M1) is a surgical laser device that emits CO2 laser at 10.6 micrometers wavelength for tissue vaporization and coagulation. It is intended for use in dermatology, plastic surgery, general surgery, gynecology, podiatry, dental, and otorhinolaryngology procedures.

Technological characteristics

The device delivers 30W maximum power in single pulse, continuous, and pulse modes with 1-1000ms pulse duration control. It features an articulated arm beam delivery system, 0.4mm spot size, LCD touchscreen and footswitch controls, and an inner air circulation cooling system. Operating specifications match the predicate device K200042 across laser type, wavelength, power output, and delivery method.

Test standards cited

IEC 60601-1 (electrical safety), IEC 60601-1-2 (EMC), IEC 60825-1 (laser safety), IEC 60601-2-22 (laser equipment), ISO 10993-5 (cytotoxicity), ISO 10993-10 (skin sensitization), and ISO 10993-23 (irritation testing).

Extracted by AI from the official FDA summary PDF →

Source

View the full FDA submission: accessdata.fda.gov

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CO2 Laser Treatment Machine (CFR3M1)

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