BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    Cold Sore Device (Model: QPZ-01)

    K Number: K222205 · Decision Oct 7, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    2
    Registration Numbers
    2
    Same Product Code
    2
    Applicant Total
    11
    Review Days
    74

    Basic Information

    Device Name
    Cold Sore Device (Model: QPZ-01)
    K Number
    K222205
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4860
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Light Tree Ventures Europe B.V.
    Date Received
    July 25, 2022
    Decision Date
    October 7, 2022
    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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