Manufacturer
Beijing HuaCheng Taike Technology Co., Ltd.Dermatological Diode Laser Systems
Beijing HuaCheng Taike Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K210663
- Device name
- Dermatological Diode Laser Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-03-05
- Decision date
- 2021-04-26
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
2—
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Not ingested
Diode laser hair removal device
K210663 references 2 predicate/reference devices
Cited as predicate
5Diode Laser Hair Removal Device
Hakon, Hakon Smart
Diode laser therapy device
Medical Diode Laser Hair Removal Device (PZ-606¿, PZ-BDT68-01, PZ-BDT68-02, PZ-BDT68-03, PZ-BDT68-04)
Diode laser therapy device (VADER)
5 submissions cite K210663 as a predicate
