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510(k) Data Aggregation

    K Number
    K972506
    Device Name
    INFINITECH BULLET ENDO ILLUMINATED PICK MANIPULATOR
    Manufacturer
    INFINITECH, INC.
    Date Cleared
    1997-10-01

    (90 days)

    Product Code
    HJM
    Regulation Number
    886.1945
    Why did this record match?
    Applicant Name (Manufacturer) :

    INFINITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Pick Manipulator is a manual tool for aiding the procedural needs of the surgeon during ophthalmic surgery, such as tissue manipulation and membrane delamination.
    Device Description
    Hand-held illuminated pick and membrane delamination instrument for ophthalmic surgery.
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    K Number
    K971950
    Device Name
    INFINITECH MULTI-SPOT SLIT LAMP LASER ADAPTER
    Manufacturer
    INFINITECH, INC.
    Date Cleared
    1997-08-01

    (65 days)

    Product Code
    HQF, HOF
    Regulation Number
    886.4390
    Why did this record match?
    Applicant Name (Manufacturer) :

    INFINITECH, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Multi-Spot Slit Lamp Laser Adapter has two functional modes available to the physician: a single spot mode and a Multi-Spot (4 spot) mode. When the a single spot mode is selected, the preexisting slit lamp laser apparatus is available for all treatment functions for which it was designed as a laser photocoagulator. The multi-spot mode is intended for use with "Green-Only" ine marcr bood me energy for panretinal photocoagulation in the treatment of proliferative retinopathy.
    Device Description
    The multi-spot slit lamp laser adapter is a non-powered reusable optical system which, when connected between the laser fiber and the slit lamp 200m optics, generates four spots in a square pattern. Through a rotary mechanism the user can select between single or multiple spot patterns. The multi-spot laser adapter mechanically mimics the fiber cable and will not effect or deactivate any existing salety interlocks. The lens system of the multi-spot adapter provides a one-to-one image of the laser fiber, therefore the spot size indicator on the zoom lens systems is not effected. The selection of single or multiple spot patterns also applies to the aiming beam, this gives the user direct and unambiguous feedback on which mode is selected before treatment begins.
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