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

    VIRULITE COLD SORE MACHINE

    K Number: DEN090012 · Decision Oct 18, 2012
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    1
    Review Days
    1206

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    Basic Information

    Device Name
    VIRULITE COLD SORE MACHINE
    K Number
    DEN090012
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    878.4860
    Medical Specialty
    General, Plastic Surgery
    Decision
    Unknown
    Applicant
    Virulite, LLC
    Date Received
    June 30, 2009
    Decision Date
    October 18, 2012
    Product Code
    OKJ
    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
    OKJ Light Based Treatment For Cold Sores Herpes Simplex Virus-1

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