Hebei Zhemai Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
The Q-Switched Nd:Yag laser is indicated for the treatment of: benign cutaneous lesions, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and birthmark; and the removal of black or blue tattoos.
The Q-switched laser therapy device is a laser system which delivers laser at a wavelength of 1064nm or 532nm and the pulse mode is single pulse. Model: FQ-L08. In the laser handpiece, there is one optical cavity containing the Nd:YAG crystal. The laser beam is directed to the treatment zone. When the laser beam contacts human tissue, the energy in the beam is absorbed, resulting in a very rapidly, highly localized temperature increase to the target tissue. The instantaneous temperature increase (thermal effect) causes the cells change of target tissue to achieve laser treatment effect. Main components include: Main unit, Smart Optics 7 Arms (articulated arm for holding of Treatment Probe), Treatment head (Laser Deliver), Foot switch (Control pulse light output), Patient goggles (Eye protection), Doctor goggles (Eye protection), Treatment head bracket (Support and fix the treatment head), Key (Start device), Power cord (Supply power), Damping (shock absorption effect).
Summary parsed at:2026-06-01 05:33:24 UTC
