Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing. The fractional scanner is only for the treatment of wrinkles and skin resurfacing. It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
The equipment is used for human tissue vaporization, coagulation in dermatology, plastic surgery, and general surgery. The classical scanner is only for the treatment of wrinkles and skin resurfacing. The fractional scanner is only for the treatment of wrinkles and skin resurfacing. It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology(ENT), gynaecology, neurosurgery, orthopaedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
Laser surgical instrument for use in general and plastic surgery and in dermatology. The proposed device is a CO2 Laser System (Model: GP900F) manufactured by SHENZHEN GSD CO., LTD. It operates with a power supply of 110-240VAC, 50-60Hz and has a maximum output power of 30W. The device features classical mode and surgical mode (Single Pulse, Continuous, Multi-Pulse) work modes, and uses CO2 as the laser medium. The CO2 laser wavelength is 10600nm, and it includes a red diode laser aiming beam with a wavelength of 650nm±10nm. The device is equipped with a console, articulated arm, and a foot switch.
Summary parsed at:2026-06-01 05:55:27 UTC
