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510(k) Data Aggregation

    K Number
    K152737
    Device Name
    Lite Touch
    Manufacturer
    Date Cleared
    2016-06-29

    (280 days)

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

    FOCUS MEDICAL LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Lite Touch™ Er YAG Laser Treatment System is intended for the vaporization, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: - · Dermatology - · Cosmetic surgery - · Plastic and general surgery - · Oral surgery - · Gynecology - · Otorhinolaryngology - · Podiatry
    Device Description
    The Lite Touch™ is an Er:YAG Laser Treatment System intended for use in the vaporization, incision, excision, dissection, ablation and/or photocoagulation of soft tissue in the following surgical specialties: Dermatology; Cosmetic surgery; Plastic and general surgery; Gynecology; Otorhinolaryngology; and Podiatry. The Lite Touch™ was previously cleared under K974460 in October 1997. This submission contains an expansion of the previously cleared indications for use. The Lite Touch™ consists of a streamlined, maneuverable cabinet that contains the laser source, control system, power supply and internal cooling system. The laser beam has a light wavelength of 2940nm and is delivered through a counterbalanced articulated arm and hand piece. There is a two stage process of dissimilar actions required to activate the laser beam. The operation of the Lite Touch™ are completely under the physician's control.
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