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510(k) Data Aggregation

    K Number
    K100474
    Device Name
    QUICKLASEDUAL+, QUICKLASE810, QUICKLASE810, QUICKLASE980, QUICKLASE980 MODEL: 3W,5W,3W,5W
    Manufacturer
    QUICKLASE LIMITED
    Date Cleared
    2010-03-16

    (26 days)

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

    QUICKLASE LIMITED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the incision, excision, ablation, vaporization, hemostasis, and treatment of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Gingivoplasty Hemostasis and coagulation Incision and drainage of abscess Operculectomy Pulpotomy Reduction of gingival hypertrophy Soft Tissue crown lengthening Vestibuloplasty Laser Soft Tissue Curettage Tissue Retraction Frenectomy and Frenotomy Gingival Troughing for crown impressions Gingivectomy Ginigival incision and excision Implant Recovery Leukoplakia Oral papillectomies Pulpotomy as an adjunct to root canal therapy Reduction of bacterial level (decontamination) and inflammation Treatment of aphthous ulcers Lesion (tumor) removal Treatment of canker sores, herpetic and other ulcers of the oral mucosa Removal of Diseased, Inflamed and necrotic soft tissue within the periodontal pocket Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithlium Sulcular debridement (removal of necrotic, diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices ingluding gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility Light activation of bleaching materials for teeth whitening Laser-assisted whitening/bleaching of teeth
    Device Description
    The laser source of the QuickLase™DUALDental Lasers or QuickLase™810/980 Dental Laser is an array of Gallium Aluminum Arsenide (GaAlAs), solid state, semiconductor diode lasers. The individual lasers comprising the array are capable of producing invisible infrared laser energy at either 810 or 980 nanometers depending upon the concentration of and construction of the epitaxial layers of the diode. The delivery system consists of a fiber optic cable with a nominal diameter of 400 microns. In all available configurations, that portion of the delivery system that is handled by the operator and/or in contact with the patient can be sterilized by heat, steam, gas, chemicals or combinations thereof. Activation of the laser occurs after the operator either selects or enters the parameters for the procedure, verifies and authorizes the parameters and depresses a footswitch which fires the laser. The footswitch is an on/off switch. The interface for input is electro-mechanical by way of a membrane switch pad. The laser operates in continuous wave or pulse mode which is selected and/or verified by the operator. A visible aiming beam is provided in the form of a visible red laser which emits not more than 5mW (user adjustable and verified) in the 640-650 nanometer wavelength range.
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