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

    Luminance Red Cold Sore Device (TN1927G)

    K Number: K251973 · Decision Sep 23, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    3
    Registration Numbers
    3
    Same Product Code
    3
    Applicant Total
    2
    Review Days
    89

    Basic Information

    Device Name
    Luminance Red Cold Sore Device (TN1927G)
    K Number
    K251973
    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
    Luminance Medical Ventures, Inc.
    Date Received
    June 26, 2025
    Decision Date
    September 23, 2025
    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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