Beijing Globalipl Development Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The CO2 Laser Equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The CO2 Laser Equipment is used for human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology.
The subject device CO2 Laser Equipment is a carbon dioxide laser used in medical and aesthetic industry. The device emits laser energy at 10.6 µm wavelength to induce human tissue vaporization, coagulation in dermatology and plastic surgery, general surgery, gynecology, podiatry, dental and otorhinolaryngology. The CO2 Laser Equipment includes two models US800 and US800N, the two models have same mechanism of action, structure, material, motherboard, PCB layout, software, principle and specification. The difference is appearance and size.
Summary parsed at:2026-06-01 05:38:30 UTC
CO2 Laser Therapy System
K212611 references 1 predicate/reference device
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