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510(k) Data Aggregation

    K Number
    K041419
    Device Name
    LIGHTFORCE LF 20/30 980NM SURGICAL DIODE LASER SYSTEM
    Date Cleared
    2004-08-26

    (90 days)

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

    MEDICAL ENERGY, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    For soft tissue Incision, Excision, Vaporization and Coagulation: * Gastroenterology * General Surgery * Gynecology * ENT/Head & Neck * Neurology * Urology * Pulmonary * Plastic Surgery Including: * Gynecology-Endometrial Ablation (K871512) * Urology Surgery (K871516) * Rectal Patho. & Hemorrhoid (K871514) * Gastro Intestinal Bleeding (K871515) * Palliation of Gastro Malignancies (K871513) * Pulmonary Obstructions (K871511A)
    Device Description
    The LIGHTFORCE 20/30 980mm Diode Surgical Laser is intended to provide the physician with a dependable laser system providing he/she the ability to incise, excise, vaporize and coagulate soft tissue in a variety of surgical procedures in various disciplines as listed: Dermatology ENT/Head & Neck Gynecology Gastroenterology General Surgery Neurosurgery Pulmonary Urology Proctology The LIGHTFORCE 20/30 980mm Diode Surgical Laser for soft tissue applications is accompanied by a variety of disposable fiber optic delivery systems for use in the different specialties. Each are compatible to all popular endoscopes on the market. A variety of Disposable Fiber Optic Delivery Systems are available for performing open and endoscopic surgical procedures with the LIGHTFORCE 20/30 980mm Diode Surgical Laser System for achieving incision, excision, vaporization and coagulation on soft tissue applications. These disposable fiber optic delivery systems are available in various sizes (200, 400, 600, and 1000 micron) for performing contact and non-contact laser surgery techniques by the operating physician to assist in achieving Incision/Excision/Vaporization/Coagulation at CONTROLLABLE depths of tissue penetration from 0.3mm up to 4mm.
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