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510(k) Data Aggregation

    K Number
    K101782
    Device Name
    MICROSTAAR MSI INJECTOR SYSTEM CARTRIDGE
    Manufacturer
    STAAR JAPAN
    Date Cleared
    2010-12-22

    (180 days)

    Product Code
    MSS
    Regulation Number
    886.4300
    Why did this record match?
    Applicant Name (Manufacturer) :

    STAAR JAPAN

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicrSTAAR™ MSI Injector System is a device intended to fold and insert STAAR™ Surgical Company Collamer phakic and aphakic one-piece and three-piece Collamer® intraocular lenses for surgical placement in the eye.
    Device Description
    The injector system is designed to facilitate the loading, folding and delivery of an intraocular lens (IOL) into the human eye through a small incision. The MicroSTAAR™ MSI injector System Cartridge utilizes three different cartridges for the insertion of an IOL lens. The three cartridges; CQ cartridge, SFC-45 cartridge and the SFC-25 cartridge are designed to facilitate a folded IOL lens for delivery. Each cartridge has a loading area which tapers down to a small tip, for the SFC-45 and SFC-25 cartridges, the lens loading area is flat and for the CQ cartridge the loading area is hinged. It is a component that is fabricated from polypropylene mixed with Glycerol Monostearate (GMS). Currently, the cartridge is cleared for fabrication from polypropylene mixed with GMS and is supplied sterile.
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