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510(k) Data Aggregation

    K Number
    K160012
    Device Name
    O-pel Laser and families of probe delivery devices
    Manufacturer
    PRECISE LIGHT SURGICAL
    Date Cleared
    2016-06-02

    (150 days)

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

    PRECISE LIGHT SURGICAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O-pel laser and families of probe delivery devices are intended for use in surgical procedures using open, laparoscopic and endoscopic incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue in use in medical specialties including Arthroscopy, Urology, ENT, Dermatology, Plastic Surgery, General Surgery, Gastroenterology, Thoracic and Pulmonary and Gynecology.
    Device Description
    The O-pel laser is an infrared laser system with an output wavelength of approximately 2μm. The O-pel laser and families of probe delivery devices (O-pel laser system) have an Intended Use of cutting and coagulating tissue, specifically incision, excision, resection, ablation, vaporization, coagulation and hemostasis of soft tissue. The O-pel laser system is comprised of the following components: -a laser console -control and display panel; -a fiber port for delivery systems; -a footswitch: -a variety of fiber optic (probe) delivery devices
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