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510(k) Data Aggregation

    K Number
    K082409
    Device Name
    SOLAR LASER ABLATION SYSTEM, MODELS: LU-1083-25, LF-1083, PC-1000, IC-1083, LW-2000, LG-2001, LK-001, PM-1083, TF-1083
    Manufacturer
    Date Cleared
    2009-01-21

    (153 days)

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

    ENDOPHOTONIX, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SOLAR™ Surgical Ablation System is indicated for delivery of 810nm, 1064nm, or 1083nm laser light to soft tissue, under visualization, during surgical procedures Indications include the ablation, or coagulation of soft tissue. The SOLAR™ Surgical Ablation System Accessories are intended for use in the support of the delivery of laser light to soft tissue during surgical procedures.
    Device Description
    The SOLAR Surgical Ablation System consists of a Cart, Laser Energy Generator (Laser Generator), Controller, an infusion set and a Track is an intraoperative, sterile, single-use device designed to apply laser energy to tissue The infusion set is a single-use device having a sterile fluid path designed for the delivery of sterile salıne solution to the Track laser tup The Track includes a rigid metallic shaft, a flexible track, and an introducer (guiding obturator) The Track further includes a laser compatible optical fiber which attaches to the Laser Generator The emitted laser energy is directed toward the targeted tissue from the end of the optical fiber which rides within the flexible Track The position of the optical fiber in relation to the target tissue is maintained constant by the method of mounting the fiber within the fiber optic housing and the design of the flexible Track itself The black markers on the Track indicate the area of tissue to be ablated and are used to set the positioning of the fiber optic housing within a given area of tissue The lines of ablation are created by independently activating the laser energy between two numbered segments, which are predetermined by the physician when positioning the flexible Track against the targeted tissue.
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