Dermatological Carbon Dioxide Laser Systems
Zhuolu Jontelaser Manufacturing 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
- K202250
- Device name
- Dermatological Carbon Dioxide Laser Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-08-10
- Decision date
- 2020-11-25
- 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 Dermatological Carbon Dioxide Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Intended Use
The Dermatological Carbon Dioxide Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
Device Description
The Dermatological Carbon Dioxide Laser Systems is a gas laser with a wavelength of 10600 nm. The laser energy density is high and the divergence angle is very small. The focused light beam is used for vaporization and coagulation of human tissue.
Summary parsed at:2026-06-01 05:48:29 UTC
Predicate devices
1CO2 Laser Therapy System
K202250 references 1 predicate/reference device
Cited as predicate
1CO2 Laser Treatment Machine (CFR3M1)
1 submission cite K202250 as a predicate