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510(k) Data Aggregation

    K Number
    K151855
    Device Name
    SLI Endoprobe, SLI DENT Bare Fiber, SLI HO Bare Fiber, SLI HCS Bare Fiber, SLI Lateral Firing Fiber
    Date Cleared
    2016-04-15

    (282 days)

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

    SURGICAL LASER INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SLI-Laser Fibers are intended for use in general surgical applications with any SMA 905 compatible approved medical laser system indicated and approved for hemostasis, coagulation, ablation, vaporization, incision, excision or resection of soft tissue or ablation or fragmentation of calculi. The fibers can be used manually or in combination with an approved, compatible endoscope, cystoscope or resectoscope. The intended use and clinical applications are described in the User Manual of the corresponding Laser.
    Device Description
    SLI Laser Probes are medical optical fibers to transfer the radiation emitted by a medical laser to its target at or in the patient. The laser beam conducted to pathological tissue destroys it thermally. The probes do not change the physical properties of the laser beam emitted by the laser device. The devices are sold sterile (EO) and are ready to use. Fiber core and cladding for the applied device are made of silica glass, coated with a hard fluoropolymer. Fiber jacket consists of highly biocompatible polymers such as ETFE. The medical device is offered in various core diameters. Laser light is coupled into the fiber via a standard SMA connector. The cannula of the endoprobes is made of 1.4301 stainless steel.
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