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510(k) Data Aggregation

    K Number
    K172375
    Device Name
    MicroSTAAR Injector System Cartridges
    Manufacturer
    STAAR Surgical Company
    Date Cleared
    2017-09-06

    (30 days)

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

    STAAR Surgical Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSTAAR® Injector System Cartridge, Model CQ is a device intended to fold and insert STAAR Surgical Company Collamer® aphakic 3-piece Intraocular Lenses for surgical placement in the eye.
    Device Description
    The MicroSTAAR Injector System Cartridge, Model CQ (also referred as "MicroSTAAR Injector CQ Cartridge" or "CQ Cartridge") is intended to facilitate the loading, folding and insertion of the STAAR Surgical Collamer® 3-piece Intraocular Lens (IOL) into the human eye following cataract extraction. The model CQ Cartridge is a single use device designed specifically to be used with the reusable MicroSTAAR MSI-PM or MSI-TM injector to deliver the STAAR Surgical Collamer® 3-piece (IOL). The CQ Cartridge is composed of polypropylene and is terminally sterilized using Ethylene Oxide.
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    K Number
    K152357
    Device Name
    MicroSTAAR Injector System Cartridges
    Manufacturer
    STAAR Surgical Company
    Date Cleared
    2015-10-30

    (71 days)

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

    STAAR Surgical Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MicroSTAAR® Injector System (MSI) is a device intended to fold and insert STAAR® Surgical Company Collamer® phakic and aphakic 1-piece intraocular lenses for surgical placement into the human eye.
    Device Description
    The MicroSTAAR® Injector System Cartridge (MSI Cartridge) is designed to facilitate the loading, folding and delivery of Collamer® phakic and aphakic intraocular lenses (ICL/IOL) into the human eve through a small incision. There is one model of MSI Cartridge in this submission, SFC-45 cartridge. The SFC-45 Cartridge is designed to lock into a corresponding MicroSTAAR® Injector System. The cartridge has a loading area on one end and a tapered tip on the other. The SFC-45 has a funnel shape, with exposed flat loading areas, and was designed to work with the Collamer® 1piece lenses manufactured by STAAR Surgical.
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