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510(k) Data Aggregation

    K Number
    K083616
    Device Name
    PATHOLASE FAMILY OF PINPOINTE AND PINPOINTE FOOTLASER ND: YAG LASERS
    Manufacturer
    PATHOLASE, INC
    Date Cleared
    2009-06-12

    (186 days)

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

    PATHOLASE, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers and the delivery accessories that are used with them are intended for use in surgical procedures involving open, laparoscopic and endoscopic ablation, vaporization, incision, and coagulation of soft tissue in the medical specialties of general and cosmetic dentistry, otolaryngology/ENT surgery, and dermatology & plastic surgery including: Oropharangeal / Dental Surgery, General Surgery, Endonasal Surgery, Podiatry, and Dermatology and Plastic Surgery.
    Device Description
    The PathoLase Family of PinPointe™ and PinPointe™ FootLaser™ Nd:YAG Lasers are comprised of the following main components: Main console containing the major electrical components, including: A Control/ Display Panel, A 1064 nm treatment laser (solid state Nd: YAG laser rod) with flashlamp and associated light regulation components and electronics; A 630 -680 nm (red) aiming beam diode laser; A Delivery device fiber-optic connector port; A Remote interlock connector (External door interlock connector); A Connector ports for the footswitch and power cord; A Accessory holder (attached to the rear of the main console); Footswitch; Medical grade power cord; Delivery Devices for Non-Contact and Contact with Intact Skin/Tissue: Guide Tip -No Standoff, Guide Tip With Standoff; Delivery Devices for Contact with Breached Surfaces (Previously Cleared in K011423): Optical Fibers, Handpieces, Handpiece Tips; Accessories: Safety Glasses, Tools: Optical Fiber Striper, Optical Fiber Cleaver (carbide wedge, ceramic, or equivalent scribe for cleaving the optical fibers).
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