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510(k) Data Aggregation

    K Number
    K213669
    Device Name
    LIGHTSCALPEL LS-4020
    Manufacturer
    Date Cleared
    2023-02-15

    (450 days)

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

    LightScalpel Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The LightScalpel LS-4020 CO2 Laser Systems are intended for use in laser surgery procedures for incision, excision, vaporization, ablation, and/or coagulation of soft tissue in specialties such as: general surgery, dermatology, dentistry and oral surgery, otorhinolaryngology, plastic and reconstructive surgery, neurosurgery, podiatry, and urology.
    Device Description
    The LightScalpel LS-4020 laser system, similar to the previously released LS-1005 and 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 um wavelength at powers adjustable from 2 - 40 Watts Continuous Wave (CW) and 2 to 20 Watts SuperPulse (SP). The systems differ only in the laser tubes used and pre-programmed values in the controlling software, which allow higher laser tube outputs for the LS-2010 and LS-4020 systems. 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 touchscreen 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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