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510(k) Data Aggregation

    K Number
    K083476
    Device Name
    NOVEON MODEL LS1100-03
    Manufacturer
    NOMIR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2008-12-22

    (28 days)

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

    NOMIR MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K071815
    Device Name
    NOVEON, MODEL LS1100-01-0968
    Manufacturer
    NOMIR MEDICAL TECHNOLOGIES, INC.
    Date Cleared
    2007-11-28

    (149 days)

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

    NOMIR MEDICAL TECHNOLOGIES, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Noveon™ (Model LS1100-01-0968) delivers continuous wave laser light in the contact or non-contact mode during surgical procedures of the skin, subcutaneous tissues and nasal passages in dermatology, plastic surgery, podiatry and otolaryngology. The device is indicated for use in applications requiring incision, excision, vaporization, hemostasis, or coagulation of soft tissue.
    Device Description
    The Noveon™ (Model LS1100-01-0968) is a Class IV Laser Surgical Instrument for use in General and Plastic Surgery and Dermatology. The device consists of the following components and accessories: 1. Laser Source and Control Unit: Two Class IV laser diodes, each providing continuous-wave laser light, one at the 870 mm and one at 930 nm wavelength. The power output of each laser is selectable from 1W to 8W in 0.1 W increments. There are two touch sensitive screens to control the optical power output of each laser and a separate emergency on/off button. 2. Foot Pedal Switch: turns the lasers on/off when the lasers are enabled. 3. Flexible Optical Fiber and End Piece: designed to be lightweight for holding the distal end of the fiber comfortably in the hand to perform procedures.
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