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510(k) Data Aggregation

    K Number
    K120810
    Device Name
    FIBEROPTIC LASER DELIVERY SYSTEM
    Manufacturer
    FIBEROPTIC FABRICATIONS INC
    Date Cleared
    2012-06-28

    (104 days)

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

    FIBEROPTIC FABRICATIONS INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The fiber optic laser delivery system is intended for delivery of laser light to soft tissue in the contact and non-contact mode during surgical procedures, including via endoscopes. The fiber optic laser delivery system is intended for use with any cleared surgical laser with an SMA 905 or SMA 905 compatible connector It is indicated for use in general surgical applications for: incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in a contact or non contact mode. It is also indicated for use in open or closed endoscopic applications where incision, excision, tissue dissection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors or lesions, tissue vaporization, hemostasis and or coagulation may be indicated. It is also indicated for use in lithotripsy with a compatible laser cleared for the desired application. It is indicated for use with Argon, KTP/532, Ho:YAG, Nd:YAG, 1.44YAG, and Diode Lasers (635-1900nm) with peak and continuous power from 1-200W. Core size 230um- 45W, 365um- 113W, 400um-135W, 600um- 200W, 800um-200W, and 1000um-200W.
    Device Description
    The fiber optic laser delivery system contains the same components and design as the already cleared CeramOptec MegaBeam optical fibers and the Biolitec radial emitting shaped fiber optic delivery system. The optical fiber is composed of quartz fiber core with a coaxially mounted protective sheath. The fibers distal tip can be several configurations and the fiber can be used with handpieces.
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