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510(k) Data Aggregation

    K Number
    DEN160030
    Device Name
    Oculeve Intranasal Tear Neurostimulator Device
    Manufacturer
    OCULEVE, INC.
    Date Cleared
    2017-04-24

    (291 days)

    Product Code
    PQJ, POJ
    Regulation Number
    886.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    OCULEVE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Intranasal Tear Neurostimulator provides a temporary increase in tear production during neurostimulation in adult patients.
    Device Description
    The 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 acutely increase tear production in adult patients. The device consists of four distinct non-sterile subassemblies: Disposable Tips, a reusable Base, a reusable Charging Station, and a reusable Cover.
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