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510(k) Data Aggregation

    K Number
    K250206
    Device Name
    Diode laser system (Night Universe; Predator)
    Date Cleared
    2025-04-24

    (90 days)

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

    Ivylaser (Beijing) Technology Co.,Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Diode laser system is used for hair removal, HR mode is for professional hair removal, and FHR is for rapid hair removal. The indications for use for the 810nm Diode Laser Module include: The HR mode and FHR mode are intended for hair removal and permanent hair reduction. Use on all skin types (Fitzpatrick 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 product is intended for the removal of unwanted body hair. It is suitable for all skin types, including tanned skin. The Diode laser system consists of the following main components: 1) The main unit, including the CPU main board, power supply module, control panel, service panel and cooling system. 2) Handlpiece, including the diode laser, TEC, handle switch, signal, cable and plug. 3) Foot switch.
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