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    K Number
    K143339
    Device Name
    Mini me
    Manufacturer
    ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.)
    Date Cleared
    2014-12-19

    (29 days)

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

    ILUMINAGE LTD.(FORMERLY SYNERON BEAUTY LTD.)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Mini me is an over-the counter device intended for the removal of unwanted hair. The Mini me is also intended for permanent reduction in hair growth following an initial treatment regimen with or without maintenance when measured at 6, 9, and 12 months.
    Device Description
    The Mini mē is a smaller version of its predicate device (K131649) and consists of a handheld unit that operates with an external power supply. Identical to its predicate device, the miniaturized version also delivers Intense Pulse Light (IPL) technology (output up to 4 J/cm²) to the treatment area for removing unwanted hair and also uses a skin contact sensor via low RF energy signal to establish skin contact prior to the emission of a pulse.
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