BEUDAMED
    FDA 510(k) FDA class 2 Unknown 🇺🇸 United States

    SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000

    K Number: K040525 · Decision Aug 17, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    0
    Applicant Total
    2
    Review Days
    169

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    Basic Information

    Device Name
    SONOPREP ULTRASONIC SKIN PERMEATION SYSTEM AND TOPICAL ANESTHETIC KIT, MODEL D2000
    K Number
    K040525
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4410
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Statement or Summary
    Summary
    Applicant
    Sontra Medical, Inc.
    Date Received
    March 1, 2004
    Decision Date
    August 17, 2004
    Product Code
    NRJ
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    NRJ Ultrasound, Skin Permeation

    Other Clearances by Sontra Medical, Inc.

    K Number Device Name
    K023713 SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000