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    K Number
    K181019
    Device Name
    Diode Laser System
    Manufacturer
    Guangzhou Huafei Tongda Technology Co., Ltd.
    Date Cleared
    2018-07-16

    (90 days)

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

    Guangzhou Huafei Tongda Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode Laser System is intended for 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 proposed device, Diode Laser System, is a surgical device, which is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI); Function module description a. Control Panel b. Main Control Module c. Constant current board module d. Temperature and humidity control system e. Handpiece module
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