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510(k) Data Aggregation

    K Number
    K063249
    Device Name
    BEAMAX
    Manufacturer
    MEDIC SHARPLIGHT LTD.
    Date Cleared
    2007-01-17

    (83 days)

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

    MEDIC SHARPLIGHT LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BEAMAX is intended for aesthetic and cosmetic use. The device is specifically indicated for removal of hair by using selective light energy.
    Device Description
    The BEAMAX applies thermal energy to human skin tissue. The energy is transmitted from a flash light source. It is transmitted to the target tissue by a hand piece that is in contact with the skin (contact mode). The device is constructed from a Man Machine Interface panel, an operating console, and a treatment hand piece.
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