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510(k) Data Aggregation

    K Number
    K984537
    Device Name
    KERATOME SYSTEM, MODEL K3000
    Manufacturer
    INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
    Date Cleared
    1999-05-14

    (144 days)

    Product Code
    HMY
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insight Technologies Instruments, Model K3000 Keratome System is designed to produce a corneal flap.
    Device Description
    Not Found
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    K Number
    K974243
    Device Name
    KERATOME SYSTEM
    Manufacturer
    INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.
    Date Cleared
    1998-01-20

    (69 days)

    Product Code
    HMY
    Regulation Number
    886.4370
    Why did this record match?
    Applicant Name (Manufacturer) :

    INSIGHT TECHNOLOGIES INSTRUMENTS, LLC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Insight Technologies Instruments, Model K-1000 Keratome System is designed to produce a corneal flap.
    Device Description
    The model K-1000 keratome features a high speed, low torque nitrogen driven motor, which drives a reciprocating surgical blade will be a single-use, disposable device that will be filed under a separate 510k. The keratome head is preset to produce a corneal resection approximately 160 microns in depth with the corresponding blade insertion and flap diameter of approximately 10.0mm. The model K-1000 keratome system is battery operated and may also operate from its charger. The power unit provides on/off footswitch controls for the keratome head and drive assembly, and suction to the suction ring. Analog gauges located on the front panel of the unit indicate nitrogen pressure and suction level supplying the appropriate connectors.
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