Beijing HuaCheng Taike Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. 1064 nm The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). 532 nm The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The Medical Ultra-Pico Laser Treatment System is intended for use in surgical and aesthetic applications in the medical specialties of dermatology and general and plastic surgery. The 1064 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for dark colored tattoo inks and for multicolored tattoos containing dark colored tattoo inks on patients with all skin types (Fitzpatrick I-VI). The 532 nm wavelength of the Medical Ultra-Pico Laser Treatment System is indicated for tattoo removal for lighter colored tattoo inks, including red and yellow inks, on patients with Fitzpatrick skin types I-III.
The Medical Ultra-Pico Laser Treatment System is the solid state laser capable of delivering energy at wavelengths of 1064nm or 532nm at short durations. The device system consists of a main unit, a light guide arm, a light guide arm tip, a spot regulator and a fooswitch. The laser output is delivered to the skin through the light guide arm delivery system terminated by the light guide arm tip. The energy and frequency are controlled from the LCD display/Touch Pad located on the front of the main unit. The LCD display is used to obtain feedback from the system, such as the number of pulses delivered or spot size selected. For treatment, the user can select the appropriate frequency and the related output energy value by pressing plus and/or minus button from the LCD display/Touch Pad located on the front of the main unit.
Summary parsed at:2026-06-01 05:18:56 UTC
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