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

    Systane iLux2

    K Number: K200400 · Decision May 21, 2020
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    2
    Review Days
    93

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    Basic Information

    Device Name
    Systane iLux2
    K Number
    K200400
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5200
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tear Film Innovations, Inc.
    Date Received
    February 18, 2020
    Decision Date
    May 21, 2020
    Product Code
    ORZ
    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
    ORZ Eyelid Thermal Pulsation System

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    Other Clearances by Tear Film Innovations, Inc.

    K Number Device Name
    K172645 iLux Instrument, iLux Disposable