BEUDAMED
    Product Code: OKJ FDA class 2 21 CFR 878.4860

    Light Based Treatment For Cold Sores Herpes Simplex Virus-1

    General, Plastic Surgery

    The Light Based Treatment For Cold Sores Herpes Simplex Virus-1 (product code OKJ) is a Class 2 device in the General, Plastic Surgery specialty (SU) regulated under 21 CFR 878.4860 and cleared through the 510(k) process. The device is intended to shorten the time to healing of herpes simplex lesions on the lips, with healing defined as patient-reported re-epithelialization. It is not an implant and does not sustain life, and is reviewed by the General, Plastic Surgery review panel.

    View on FDA
    510(k)s
    4
    FEI Numbers
    3
    Registration Numbers
    3
    Unique Applicants
    4
    Years Active
    13

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    Basic Information

    Product Code
    OKJ
    Device Class
    FDA class 2
    Regulation Number
    878.4860
    Medical Specialty
    General, Plastic Surgery
    Review Panel
    SU
    Submission Type
    1

    Device Characteristics

    ✗
    GMP Exempt
    ✗
    Implant
    ✗
    Life Sustain/Support
    ✗
    Third Party
    —
    Summary Malfunction Reporting

    Definition

    Shortens time to healing of herpes simplex lesions on the lips, with time to healing defined as the time to patient described re-epithelialization.

    510(k) Clearance History

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    Related 510(k) Clearances

    This FDA classification is associated with 4 510(k) clearances via K numbers.

    K Number Device Name
    K251973 Luminance Red Cold Sore Device (TN1927G)
    K241155 Cold Sore Device (QPZ-03)
    K222205 Cold Sore Device (Model: QPZ-01)
    DEN090012 VIRULITE COLD SORE MACHINE

    FEI Numbers

    This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.

    Registration Numbers

    This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.