Manufacturer
Haidari Beauty Technology (Beijing) Co., Ltd.CO2 Laser Treatment Machine (CFR3M1)
Haidari Beauty Technology (Beijing) Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K253920
- Device name
- CO2 Laser Treatment Machine (CFR3M1)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-12-08
- Decision date
- 2026-03-03
- Submission type
- Traditional
- Technology type
- CO2(AI inferred)
- Clinical applications
- Surgical cuttingSkin resurfacing
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The CO2 Laser Treatment Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Intended Use
The CO2 Laser Treatment Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Description
The device emits CO2 laser at the wavelength of 10.6µm, which is the spectral line in the far infrared range. The device is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. Carbon dioxide laser is a laser beam generated by electrically excited carbon dioxide gas molecules, which has a very small divergence angle and high energy density. After focusing, it can reach a power of several kilowatts per square centimeter. Cutting, vaporization, carbonization, solidification and irradiation. The unfocused original light beam irradiates the lesion tissue, which can cause coagulation of biological tissue. The CO2 laser penetrates the tissue deeper, and after irradiation, it can heat and treat the deep tissue.
Summary parsed at:2026-06-01 05:18:58 UTC
Predicate devices
2CO2 Laser System
Dermatological Carbon Dioxide Laser Systems
K253920 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K253920 as a predicate