Manufacturer
Zhengzhou Bestview ST Co., Ltd.CO2 Laser Machine, Model: BW-203B
Zhengzhou Bestview ST 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
- K211735
- Device name
- CO2 Laser Machine, Model: BW-203B
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-06-07
- Decision date
- 2021-10-22
- 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 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 Machine is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Description
The CO2 laser machine has two modes, continuous mode and multi-pulse mode. It utilizes CO2 laser to vaporize and heat tissue. During the treatment, the water in skin tissues absorbs laser energy and then vaporizes. Laser parameters and other system features are controlled from the control panel on the console, which provides an interface to the system's micro-controller through a LCD touch-screen.
Summary parsed at:2026-06-01 05:43:15 UTC
Predicate devices
1CO2 Laser System
K211735 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K211735 as a predicate