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510(k) Data Aggregation

    K Number
    K212478
    Device Name
    Dermatological diode laser system
    Date Cleared
    2022-01-14

    (158 days)

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

    Beijing Stelle Laser Technology Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dermatological diode laser 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
    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. The laser light targets on melanin and treat selectively in a precise way. Melanin could absorb the energy from the laser, which would result in temperature rapid increase, to destroy germinal cell and does not damage epidermis and the surrounding normal tissue. After laser exposure, the debris of these cells is removed from the body by phagocytic cells. The four models of different products produced by our company are consistent in Wavelength , Energy Fluence, Pulse Duration, Energy deviation, Spot Size, Frequency and so on. It's just that the shell is slightly different.
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