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510(k) Data Aggregation

    K Number
    K163632
    Device Name
    Katalyst Cyclophotocoagulation Probe
    Manufacturer
    Katalyst Surgical, LLC
    Date Cleared
    2017-06-15

    (175 days)

    Product Code
    LQJ, FFS, MPA
    Regulation Number
    886.4390
    Why did this record match?
    Product Code :

    LQJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Katalyst Cyclophotocoagulation Probe is intended, when used with an infrared laser, for Transscleral Cyclophotocoagulation (TSCPC) of the ciliary process.
    Device Description
    The Cycloprobe is a single use device sold sterile. The Cycloprobe is made out of one fiberoptic, one laser machine connector, one handle for surgeon manipulation, one clear tip for placement on the eye, and a protective sheath over the fiber. On the distal side, the fiberoptic is terminated by a connector that attaches to the laser machine. On the other side, it is terminated by a fiber that has a ball lens formed onto the end that protrudes slightly from the clear tip. The connector configuration is chosen based on the surgeons' laser machine requirements. The total length of the device is 7 feet.
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