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

    LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)

    K Number: DEN100017 · Decision Jun 28, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    11
    Applicant Total
    9
    Review Days
    323

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    Basic Information

    Device Name
    LIPFLOW THERMAL PULSATION SYSTEM (FORMERLY MANUAL MINI SYSTEM)
    K Number
    DEN100017
    Device Class
    FDA class 2
    Clearance Type
    Post-NSE
    Regulation Number
    886.5200
    Medical Specialty
    Ophthalmic
    Decision
    Unknown
    Applicant
    Tearscience, Inc.
    Date Received
    August 9, 2010
    Decision Date
    June 28, 2011
    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
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    K152869 LipiView II Ocular Surface Interferometer
    K133127 LIPIFLOW THERMAL PULSATION SYSTEM
    K122481 LIPIVIEW OCULAR SURFACE INTERFEROMETER
    K112704 LIPIFLOW THERMAL PULSATION SYSTEM
    K091935 LIPIVIEW OCULAR SURFACE INTERFEROMETER