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510(k) Data Aggregation

    K Number
    K241860
    Device Name
    Diode Laser Hair Removal System
    Date Cleared
    2024-09-25

    (90 days)

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

    Beijing Winkonlaser Technology Limited.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diode Laser Hair Removal System 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
    808nm diode laser using selective light absorption, the Diode 808 laser is preferentially absorbed by the melanin of the hair. The light energy is taken up by the hair follicle and converted to heat energy, and minimal energy is transferred to the skin. This preferentially heats the hair and its DNA, while reducing oxygen organization around hair follicle - reducing the chance of hair regrowth. Special cooling technology is applied simultaneously during treatment to cool the skin and protect skin. Diode Laser Hair Removal is the safest and fastest at the present. It 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.
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