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    K Number
    K110228
    Device Name
    NIDEK MULTICOLOR LASER PHOTOCOAGULATOR
    Manufacturer
    NIDEK INCORPORATED
    Date Cleared
    2011-02-23

    (28 days)

    Product Code
    HQB, GEX, HQF
    Regulation Number
    886.4690
    Why did this record match?
    Applicant Name (Manufacturer) :

    NIDEK INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Nidek Multicolor Laser Photocoagulator System MC-500 is intended to be used in ophthalmic surgical procedures, including retinal and macular photocoagulation, iridotomy and trabeculoplasty.
    Device Description
    The Nidek Multicolor Laser Photocoagulator System MC-500 ("MC-500") is a conventional ophthalmic laser photocoagulator system with treatment light wavelengths of 532 um, 577 nm, and 647 nm. The system is comprised of a diode aim and treatment lasers, graphical user interface, slit lamp and binocular indirect ophthalmoscope delivery units, and a footswitch.
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