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510(k) Data Aggregation

    K Number
    K032703
    Device Name
    INNOVATECH STRAIGHT LASER PROBE, MODEL 420-10
    Date Cleared
    2003-10-24

    (52 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATECH SURGICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For photocoagulation during ophthalmic surgery. This device delivers laser energy to target tissue, causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
    Device Description
    The Innovatech Straight Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber with PVC jacket, a Delrin handpiece and a 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
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    K Number
    K032704
    Device Name
    INNOVATECH ILLUMINATING LASER PROBE, MODEL 420-30
    Date Cleared
    2003-10-24

    (52 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    INNOVATECH SURGICAL INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For photocoagulation during ophthalmic surgery. To be used with (specified equipment). For photocoagulation and illumination during ophthalmic surgery. This Indications for Use: r or photoougaliation, as well as laser energy, to target tissue causing coagulation. Spot size can be varied by altering the distance between the tissue and the probe tip.
    Device Description
    The Innovatech Illuminating Laser Probe is an ophthalmic laser delivery device. By its design, it does not generate, intensify or significantly reduce energy. It consists of a connector that is plugged into an existing laser source, a glass fiber for laser delivery and acrylic fiber for illumination with PVC jacket, a Delrin handpiece and 304 stainless needle. The specific laser source to which the probe is connected will be specified in the "Indications for Use."
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