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

    LASER FLARE METER

    K Number: K913852 · Decision Feb 7, 1992
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    10
    Review Days
    164

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    Basic Information

    Device Name
    LASER FLARE METER
    K Number
    K913852
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Kowa Optimed, Inc.
    Date Received
    August 27, 1991
    Decision Date
    February 7, 1992
    Product Code
    HJO
    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
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

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    Other Clearances by Kowa Optimed, Inc.

    K Number Device Name
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    K955442 KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
    K954781 KOWA GENESIS HAND-HELD FUNDUS CAMERA
    K954780 KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
    K954782 KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
    K880920 LASER FLARE CELL METER FC-1000
    K881219 AUTOMATIC PERIMETER, AP-340