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

    TrueTear Intranasal Tear Neurostimulator

    K Number: K193589 · Decision Aug 31, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0
    Same Product Code
    1
    Applicant Total
    6
    Review Days
    252

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    Basic Information

    Device Name
    TrueTear Intranasal Tear Neurostimulator
    K Number
    K193589
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5310
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Allergan
    Date Received
    December 23, 2019
    Decision Date
    August 31, 2020
    Product Code
    QBR
    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
    QBR Intranasal Electrostimulation Device For Dry Eye Symptoms

    Similar 510(k) Clearances

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

    TrueTear Intranasal Tear Neurostimulator

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

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