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    K Number
    K051255
    Device Name
    LUMIPHASE-R
    Manufacturer
    OPUSMED INC.
    Date Cleared
    2005-07-01

    (46 days)

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

    OPUSMED INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LumiPhase-R ™ is indicated for treatment of wrinkles, rhytids and fine lines in the periorbital region.
    Device Description
    The LumiPhase-R system delivers visible light at a wavelength of 660 nanometers. This LED device consists of three interconnected sections: the base which houses the power supply, the articulated arm and the treatment head consisting of the controller, the ventilation (heat sink) system, the LED based optics and the positioning system.
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