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510(k) Data Aggregation

    K Number
    K062071
    Device Name
    PROMETEY, MODEL G1-03
    Manufacturer
    SPECTRUM INTERNATIONAL
    Date Cleared
    2006-09-28

    (69 days)

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

    SPECTRUM INTERNATIONAL

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dental Soft Tissue Indications for incision, excision, vaporization, ablation and coagulation of oral soft tissues, including: Excision and Incision Biopsies, Hemostasis and Coagulation, Treatment of canker sores, herpetic and aphthous ulcers, Frenectomy and Frenotomy, Gingival Incision and Excision, Gingivectomy and Gingivoplasty, Incision and Drainage of Abscess, Operculectomy, Oral Papillectomy, Removal of Fibromas and Hyperplastic tissues, Exposure of un-erupted / partially erupted teeth, Implant recovery, Tissue retraction / troughing, Leukoplakia, Pulpotomy, Soft tissue crown lengthening, Vestibuloplasty. Laser Periodontal Procedures, including: Laser soft tissue curettage, Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium, Sulcular debridement (removal of diseased, inflamed and necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility). Teeth Whitening Procedures, including: Light Activation of bleaching materials for teeth whitening, Laser-assisted whitening / bleaching of teeth.
    Device Description
    The PROMETEY ™ diode laser system is a device for delivering laser power to treated surfaces within oral cavity. This power is produced by solid-state laser diodes, which provide a consistent generation of laser power in 810 ± 10 nm spectral region with maximum power of 3 Watts. The laser power is delivered to the treatment site by means of fiber optic cables available in 400, 300 and 200 um core diameters. These cables provide safe transmission of laser power to the surgical site without creating undue risk to a patient or operatory staff by errant or collateral laser emissions. The device features front-panel keypad used to activate 650 nm aiming beam, set power output and select continuous or pulsed operation mode. The distal end of delivery fiber cable is contained within a metal handpiece with a disposable tip /cannula. A standard foot-switch controls initiation /termination of laser power from the delivery fiber.
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