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

    VEIN-GOGH INSTRUMENT

    K Number: K112334 · Decision May 8, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    5
    Registration Numbers
    5
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    270

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    Basic Information

    Device Name
    VEIN-GOGH INSTRUMENT
    K Number
    K112334
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Refine USA, LLC
    Date Received
    August 12, 2011
    Decision Date
    May 8, 2012
    Product Code
    ONQ
    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
    ONQ Electrosurgical Coagulation For Aesthetic

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