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    K Number
    K040525
    Device Name
    SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000
    Manufacturer
    SONTRA MEDICAL INC.
    Date Cleared
    2004-08-17

    (169 days)

    Product Code
    NRJ
    Regulation Number
    878.4410
    Why did this record match?
    Product Code :

    NRJ

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sontra Medical Corporation SonoPrep® Ultrasonic Skin Permeation System and The Oollar Tray is indicated for the temporary disruption of the outer layer of skin prior to the application of OTC Topical 4% Lidocaine Cream, for local dermal anesthesia prior to a needle insertion or IV procedure.
    Device Description
    The SonoPrep® Ultrasonic Skin Permeation System is a portable battery operated reusable device that disrupts the stratum corneum layer of the skin by means of cavitation of a fluid with ultrasonic energy. The result of the treatment allows the rapid onset of topical OTC lidocaine 4%.
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