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510(k) Data Aggregation

    K Number
    K123888
    Device Name
    Z CARTRIDGE IOL DELIVERY SYSTEM
    Date Cleared
    2013-04-15

    (118 days)

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

    AAREN SCIENTIFIC, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Aero Z Cartridge IOL Delivery System is indicated to fold and insert Aaren Scientific IOLs that have the use of this inserter in their approved labeling.
    Device Description
    The Aero Z Cartridge IOL Delivery System is a two-part device comprised of a reusable handpiece and single use disposable cartridge. The single use disposable cartridge is , fabricated from polypropylene with a glyceryl monostearate (GMS) agent incorporated for lubricity. It is intended for single use only and is provided sterile. The reusable handpiece is titanium, is supplied non-sterile and is designed to accommodate the cartridge and lens for delivery of the lens into the eye. The reusable handpiece is supplied in both a push-and-turn and screw type configuration.
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