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510(k) Data Aggregation

    K Number
    K141838
    Device Name
    SOL PORTABLE DIODE LASER UNIT (WITH WIRELESS FOOT CONTROL)
    Date Cleared
    2014-07-25

    (17 days)

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

    REGULATORY TECHNOLOGY SERVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SOL Portable Diode Laser Unit (with wireless foot control) is intental intracral soft tissue general, only maxills-facial and cosmetic surgery. It is intended for ablating, vaportizing and coagulation of soft tissues using a fiber optic delivery system. Include excision and incision biopsies; hemostatic assissance; treatment of apthous ulcers; frenotomy; gingival incision and excision; gingivectory; gingivoplasty; incisiog and draining abscesses; operculectomy; oral papillectomy; removal of fibromas; soft tissue crown lengthening; sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket); tissue retraction for impression; vestibuloplasty.
    Device Description
    The SOL Portable Diode Laser, or SOL, is a battery operated counter top dental surgical and therapeutic diode laser. The SOL comprises five main assemblies; a housing, an optical fiber with hand piece, and optical fiber "tip", a foot switch and an auxiliary power supply. The housing contains the system PCBs with system display, battery, control panel with indicators, auxiliary power and footswitch jacks, safety key switch, system power On/Off switch, diode laser with 808 nm working beam and 405 nm aiming beam, heat dissipation assembly with over temperature thermistor and fiber storage wrap. The optical fiber with hand piece comprises a single glass core fiber contained inside an outer PVC jacket, connectors for diode and tip coupling and a hand piece for precise delivery of laser energy to the target tissue. The optical fiber tip is a single patient disposable glass core fiber for delivery of laser energy to the target that couples to the hand piece fiber. A wireless foot control can be used to activate the laser working beam. The auxiliary power supply connects to the housing and is used to charge the system battery and as a power source for the diode laser in the event of low battery capacity.
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    K Number
    K141323
    Device Name
    VTI SUCTION IRRIGATION SYSTEM
    Date Cleared
    2014-06-04

    (15 days)

    Product Code
    Regulation Number
    876.1500
    Why did this record match?
    Applicant Name (Manufacturer) :

    REGULATORY TECHNOLOGY SERVICES, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    To be used as a general purpose suction and/or irrigation device during open or laparoscopic surgical procedures; including general, gynecologic, thoracic, otolaryngologic, plastic and urologic.
    Device Description
    Not Found
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