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510(k) Data Aggregation

    K Number
    K062248
    Device Name
    AZURYT MODEL CTL 1401, CO2 SURGICAL LASER SYSTEM
    Manufacturer
    NORTH AMERICAN CLINICAL LASERS, LTD.
    Date Cleared
    2006-08-17

    (14 days)

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

    NORTH AMERICAN CLINICAL LASERS, LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Azuryt Model CTL 1401, CO2 Surgical Laser System is indicated for the incision, excision, ablation, vaporization and coagulation of body soft tissues, including intraoral tissues. These systems can be used in a variety of medical specialties, including general and plastic surgery, dentistry, oral/maxillofacial surgery, dermatology, gastroenterology, gynecology, otorhinolaryngology, aesthetical surgery, neurosurgery, oculoplastic, orthopedic, pulmonary/thoracic surgery, and urology.
    Device Description
    The, Azuryt Model CTL 1401 CO2 Surgical Laser System is a CO2 laser consisting of a power supply, cooling system, laser head, articulated arm, handpiece, microcontroller and control panel.
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