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510(k) Data Aggregation

    K Number
    K062259
    Device Name
    ISCIENCE SURGICAL FIBEROPTIC ILLUMINATOR, MODEL FI - 100
    Manufacturer
    ISCIENCE SURGICAL
    Date Cleared
    2006-08-15

    (11 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISCIENCE SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iScience Surgical Fiberoptic Illuminator is indicated for illumination during anterior and posterior segment ophthalmic surgery.
    Device Description
    The iScience Surgical Fiberoptic Illuminator (FI) is a portable light source intended to provide illumination during anterior and posterior segment ophthalmic surger. It is designed to be used only with the iScience Surgical iTrack Ophthalmic Microcannula to illum nate tissues during advancement into intraocular structures of the anterior and posterior segment. The FI consists of a splash proof sheet metal enclosure with panel mounted rocker switches for operational control, and a custom light output connector. The FI houses a laster dionel illumination source, and is specific for the iScience Surgical iTrack Ophthalmic Microcannula. The FI is not intended to be sterilized or placed in a sterile enclosure. The FI has a custom designed light output connector that contains two redundant safety interlock switches. These switches, in conjunction with electronic circuitry in the Fly ensure that laser light can only emanate from the laser aperture when an iScience Surgical iTrack Ophthalmic Microcannula is installed in the connector. The interlock switches independently detect the proper insertion of the iScience Surgical iTrack Ophthalmic Microoannulaipe into thre connector, ensuring that the microcannula is fully engaged and retained in the connector before laser output is enabled.
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    K Number
    K050716
    Device Name
    ISCIENCE SURGICAL VISCOINJECTOR
    Manufacturer
    ISCIENCE SURGICAL CORPORATION
    Date Cleared
    2005-04-21

    (31 days)

    Product Code
    MRH
    Regulation Number
    880.5725
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISCIENCE SURGICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iScience Surgical Ophthalmic Viscoinjector is a manually operated device for precision delivery of small amounts of viscous fluid such as a sterile viscoelastic solution pre-packaged in a cartridge, for example Healon, HealonGV and Healon5 manufactured by Advanced Medical Optics Inc., and Ocucoat manufactured by Bausch and Lomb.
    Device Description
    The iScience Surgical Ophthalmic Viscolnjector consists of a holder for a viscoelastic The loolorios bargreates a manually operated screw driven plunger. For use, a cantridge of viscoelastic solution is placed into the body of the Ophthalmic Viscolnjector. A needle inside the Ophthalmic Viscolnjector pierces the septum of the viscoelastic cartridge as it is seated within the body cavity. The cap from the Ophthalmic Cannage as it is connected to the body to secure the cartridge of viscoelastic solution inside the Viscolnjector. The thumbwheel is rotated clockwise thereby advancing the screw driven plunger to deliver viscoelastic solution. The end of the screw has a bushing that contacts the stopper in the viscoelastic cartridge. As the screw is advanced at a controlled rate the stopper displaces fluid out through the needle that has pierced the septum. The opposite, blunt end of the needle is embedded in a male Luer lock connector. This connector may be mated to a female Luer connector and the viscoelastic solution delivered. Markings on the thumbwheel, cap, and body of the Viscolnjector are provided to assist in determining the number of complete or partial thumbwheel rotations and thus relate to the amount of fluid delivered.
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    K Number
    K041108
    Device Name
    ISCIENCE SURGICAL OPHTHALMIC MICROCANNULA
    Manufacturer
    ISCIENCE SURGICAL CORPORATION
    Date Cleared
    2004-06-22

    (55 days)

    Product Code
    MPA
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    ISCIENCE SURGICAL CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iScience Surgical Ophthalmic Microcannula is indicated for fluid infusion and aspiration, as well as illumination, during surgery.
    Device Description
    The iScience Surgical Ophthalmic Microcannula, or iTRACK, is a flexible microcannula designed to allow atraumatic cannulation of spaces in the eye such as the anterior chamber and posterior segment, for infusion and aspiration of fluids during surgery, including saline and viscoelastics. The microcannula incorporates an optical fiber to allow transmission of light to the microcannula tip for surgical illumination and guidance.
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