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510(k) Data Aggregation

    K Number
    K210663
    Device Name
    Dermatological Diode Laser Systems
    Manufacturer
    Beijing HuaCheng Taike Technology Co., Ltd.
    Date Cleared
    2021-04-26

    (52 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Beijing HuaCheng Taike Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dermatological Diode Laser Systems(Model: CM01D/CM02D) is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-V), including tanned 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 s laser handpiece. The emission laser is activated by a foot-switch. There are 2 models included,CM01D,CM02D, the two models have same mechanism of action, principle and specification, only difference is the configuration.
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