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510(k) Data Aggregation

    K Number
    K193589
    Device Name
    TrueTear Intranasal Tear Neurostimulator
    Manufacturer
    Allergan
    Date Cleared
    2020-08-31

    (252 days)

    Product Code
    QBR
    Regulation Number
    886.5310
    Why did this record match?
    Product Code :

    QBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueTear Intranasal Tear Neurostimulator provides a tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
    Device Description
    The TrueTear device is a prescription only, non-implantable, electrostimulation device intended to increase tear production for improvement in dry eye symptoms. The device's technological principle is the application of low-level electrical stimulation to sensory neurons located in the nose to acutely increase tear production and improve dry eye symptoms. The device consists of three distinct non-sterile subassemblies - a base unit which controls and produces electrical stimulation waveform and enables the patient to control the neurostimulation, a disposable tip that is inserted into the nose and provides the contact surface for the stimulation to the target tissue located in the nose, and a charger case that protects the device and replenishes the sealed battery inside the base unit between uses.
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    K Number
    DEN170086
    Device Name
    TrueTear Intranasal Tear Neurostimulator
    Manufacturer
    Allergan
    Date Cleared
    2018-05-17

    (206 days)

    Product Code
    QBR
    Regulation Number
    886.5310
    Why did this record match?
    Product Code :

    QBR

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The TrueTear Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation to improve dry eye symptoms in adult patients with severe dry eye symptoms.
    Device Description
    The TrueTear Intranasal Tear Neurostimulator is a non-surgical, non-implantable device intended for the application of low level electrical stimulation to sensory neurons of the nasal cavities to increase tear production to improve dry eye symptoms in adult patients with severe dry eye symptoms. The device consists of four distinct non-sterile subassemblies: Disposable Tips, a reusable Base Unit, a reusable Charging Station, and a reusable Cover. The device design has not been significantly modified from the device granted under DEN160030, with technical changes including enabling Bluetooth functionality for one-way wireless communication, removal of material used in the disposable tip, disabling of the tip detection feature in the Base Unit, and addition of an optional mobile application (TrueTear App) for reading and summarizing device usage data.
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