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

    LipiFlow Thermal Pulsation System

    K Number: K192623 · Decision Oct 22, 2019
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    9
    Review Days
    29

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    Basic Information

    Device Name
    LipiFlow Thermal Pulsation System
    K Number
    K192623
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    886.5200
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Tearscience, Inc.
    Date Received
    September 23, 2019
    Decision Date
    October 22, 2019
    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 Tearscience, Inc.

    K Number Device Name
    K182506 LipiScan Dynamic Meibomian Imager
    K161357 LipiFlow Thermal Pulsation System
    K152869 LipiView II Ocular Surface Interferometer
    K133127 LIPIFLOW THERMAL PULSATION SYSTEM
    K122481 LIPIVIEW OCULAR SURFACE INTERFEROMETER
    K112704 LIPIFLOW THERMAL PULSATION SYSTEM
    DEN100017 LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
    K091935 LIPIVIEW OCULAR SURFACE INTERFEROMETER