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510(k) Data Aggregation

    K Number
    K061871
    Device Name
    LEICA MODEL FL800
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Date Cleared
    2006-09-20

    (79 days)

    Product Code
    IZI, EPT
    Regulation Number
    892.1600
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEICA MICROSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Leica FL800 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.
    Device Description
    The Leica FL800 device is a surgical microscope accessory used for viewing intra-operative blood flow in the cerebral vascular area. It allows the surgical microscope to produce excitation light and resolve florescence light from the fluorescent agent ICG. The Leica FL800 is an accessory to the Leica M520 OH3 Neurosurgical Microscope and is comprised of five components: Standard Leica M520 OH3 Microscope, Sony XC-E150 NIR (near infra-red) camera, Leica Dual CCD Surgical Microscope Camera Adapter, Leica modification of standard 300 Watt Xe light source, and Leica FL800 electronic control unit. It is labeled for use with Akorn Inc.'s Indocyanine-Green (ICG).
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    K Number
    K013259
    Device Name
    PORTABLE NON-CONTACT TONOMETER, MODEL PT100
    Manufacturer
    LEICA MICROSYSTEMS, INC. O.I.D.
    Date Cleared
    2002-02-20

    (142 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEICA MICROSYSTEMS, INC. O

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PT100 is a hand held non contact tonometer intended to measure the intraocular pressure of the eye.
    Device Description
    Not Found
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    K Number
    K990869
    Device Name
    LEICA AT550
    Manufacturer
    LEICA MICROSYSTEMS, INC.
    Date Cleared
    1999-06-07

    (83 days)

    Product Code
    HKX
    Regulation Number
    886.1930
    Why did this record match?
    Applicant Name (Manufacturer) :

    LEICA MICROSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The AT550 is intended to measure intraocular pressure of the eye.
    Device Description
    Not Found
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