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510(k) Data Aggregation

    K Number
    K141658
    Device Name
    LIGHT SCALPEL
    Manufacturer
    LIGHT SCALPEL LLC
    Date Cleared
    2014-10-22

    (124 days)

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

    LIGHT SCALPEL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightScalpel LS-1005 & LS-2010 CO2 Laser Systems are in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as; general surgery, dermatology, gynecology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, neurosurgery, podiatry, and urology.
    Device Description
    The LightScalpel LS-1005 / LS-2010 laser systems are mobile platforms that utilizes a radio frequency (RF) excited carbon dioxide (CO2) laser tube to produce an infrared beam at a nominal 10.6 µm wavelength at powers adjustable from 2 to 10 and 2 to 20 Watts Continuous Wave (CW) respectively. The systems differ only in the laser tube used, pre-programmed values in the controlling software, which allow higher laser tube drive for the LS-2010 system, and physical height and weight. Laser energy is conducted to the point of application by a flexible fiber waveguide and handpiece assembly. Laser system operation is controlled by operator input on a touch-screen display panel. The RF laser drive is modulated to provide additional pulsed and superpulse emission modes selected from the laser system control panel.
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