BEUDAMED
    Product Code: QBR FDA class 2 21 CFR 886.5310

    Intranasal Electrostimulation Device For Dry Eye Symptoms

    Ophthalmic

    The Intranasal Electrostimulation Device for Dry Eye Symptoms is a prescription ophthalmic device intended to temporarily increase tear production using intranasal neurostimulation to improve dry eye symptoms, used in patients suffering from dry eye disease. It is classified as a Class 2 device under regulation 886.5310, requiring 510(k) premarket notification, and falls within the Ophthalmic (OP) medical specialty. The product code is QBR. It is not an implant and is not life-sustaining.

    View on FDA
    510(k)s
    2
    FEI Numbers
    0
    Registration Numbers
    0
    Unique Applicants
    1
    Years Active
    2

    Research product code QBR in seconds

    The Research Assistant summarizes clearances, adverse event trends and regulation context for a product code — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Product Code
    QBR
    Device Class
    FDA class 2
    Regulation Number
    886.5310
    Medical Specialty
    Ophthalmic
    Review Panel
    OP
    Submission Type
    1

    Device Characteristics

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

    Definition

    This device type is intended to temporarily increase tear production using neurostimulation to improve dry eye symptoms. For prescription use only.

    510(k) Clearance History

    Loading...

    Related 510(k) Clearances

    This FDA classification is associated with 2 510(k) clearances via K numbers.

    K Number Device Name
    K193589 TrueTear Intranasal Tear Neurostimulator
    DEN170086 TrueTear Intranasal Tear Neurostimulator