Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser System is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
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
CO2 Laser System
K260257 references 1 predicate/reference device
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