Beijing HuaCheng Taike Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Dermatological Diode Laser Systems (Model: CM01D/CMO2D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Dermatological Diode Laser Systems(Model:CM01D/CMO2D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Dermatological Diode Laser Systems utilize a semiconductor diode with invisible infrared radiation as a laser source to emit 808nm wavelength laser which is absorbed by melanin. The laser power is delivered to the treatment area via a laser handpiece. The emission laser is activated by a foot-switch. There are 2 models included, CMO1D, CMO2D, the two models have the same mechanism of action, principle and specification, only difference is the configuration. The detailed difference shown as follows: CM01D has a 15.6" color touch LCD screen, treatment laser spot of 10 x 30 mm, pulse width of 15-400 ms (continuously adjustable), energy density of 05-100J/cm2 (continuously adjustable), pulse frequency of 1-10Hz, size of 63*52*46cm, and weight of 3Kg. CM02D has a 4.3" color touch LCD screen, treatment laser spot of 9 x 12 mm, pulse width of 35-400 ms (continuously adjustable), energy density of 03-30J/cm2 (continuously adjustable), pulse frequency of 1-3Hz, size of 49*44*139cm, and weight of 75Kg.
Summary parsed at:2026-06-01 05:42:47 UTC
