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510(k) Data Aggregation

    K Number
    K232709
    Device Name
    Diode laser therapy device
    Manufacturer
    Hebei Zhemai Technology Co., Ltd
    Date Cleared
    2023-11-30

    (86 days)

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

    Hebei Zhemai Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Diode laser therapy device 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
    Diode Laser Hair Removal adopts Gold standard 808nm semi-conductor laser, based on selective photothermolysis principle, through specific wavelength, penetrate epidermis into dermis, optical energy was absorbed and translated into heat energy with restraining hair follicle tissues, and produce photothermal effect. It takes laser energy in hair follicle with rich in melanin, surrounding tissues absorb less even no energy, reach to restrained melanin of hair follicles and remove hair. Meanwhile, don't hurt around tissues and virtually pain-free remove surplus hair; eventually, reach to permanent Hair Removal. The Diode laser therapy device 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 laser handpiece. The emission laser is activated by a foot-switch.
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    K Number
    K232716
    Device Name
    Q-Switched Nd:Yag laser
    Manufacturer
    Hebei Zhemai Technology Co., Ltd
    Date Cleared
    2023-11-30

    (86 days)

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

    Hebei Zhemai Technology Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Q-Switched Nd: Yag laser is indicated for the treatment of: benign cutaneous lessons, such as Warts, Scars, Striae and Psoriasis; benign pigmented lesions, such as Lentigines, nevus, and the removal of black or blue tattoos.
    Device Description
    The Q-switched laser therapy device is laser system which delivers laser at a wavelength 1064nm or 532nm and the pulse mode is single pulse. In 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.
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