Manufacturer
Beijing Superlaser Technology Co., Ltd.CO2 Laser System
Beijing Superlaser Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K200042
- Device name
- CO2 Laser System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-01-08
- Decision date
- 2020-06-09
- 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 System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Intended Use
The CO2 Laser System 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.
Summary parsed at:2026-06-01 05:47:36 UTC
Predicate devices
2CO2 Laser Therapy Machine
CO2 Laser Therapy System
K200042 references 2 predicate/reference devices
Cited as predicate
4CO2 Laser Machine, Model: BW-203B
CO2 Laser System (CO2 Laser SST-L23)
CO2 Laser Treatment Machine (CFR3M1)
CO2 Laser System
4 submissions cite K200042 as a predicate