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

    iTEAR100 Neurostimulator

    K Number: K213623 · Decision Mar 16, 2022
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    1
    Review Days
    120

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    Basic Information

    Device Name
    iTEAR100 Neurostimulator
    K Number
    K213623
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5305
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Olympic Ophthalmics
    Date Received
    November 16, 2021
    Decision Date
    March 16, 2022
    Product Code
    QKV
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    QKV Electromechanical Tear Stimulator

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (QKV), ordered by most recent decision date.

    iTEAR Neurostimulator

    FDA 510(k)
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