Manufacturer
Sanhe Meditech Co., Ltd.CO2 Laser System
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
- K260257
- Device name
- CO2 Laser System
- Company
- Sanhe Meditech Co., Ltd.
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2026-01-28
- Decision date
- 2026-03-28
- 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 working principle of CO2 laser system instrument is that the laser power supply drives the laser emitter to emit light, through the refraction of several mirrors, the light is transmitted to the treatment head, and then the light is aggregated into one point by the focusing mirror, which can reach a very high temperature, so that the treatment area can be sublimated into gas in an instant, so as to achieve the purpose of treatment. The CO2 laser system comprises essential components including the main unit, treatment handpiece, foot switch, and various accessories. The wavelength of CO2 laser system is 10600nm.
Summary parsed at:2026-06-01 05:19:14 UTC
Predicate devices
1CO2 Laser System
K260257 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 K260257 as a predicate