BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    KERATOLUX

    K Number: K854383 · Decision Nov 12, 1985
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    6
    Applicant Total
    44
    Review Days
    13

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    Basic Information

    Device Name
    KERATOLUX
    K Number
    K854383
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1290
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Carl Zeiss, Inc.
    Date Received
    October 30, 1985
    Decision Date
    November 12, 1985
    Product Code
    HPL
    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
    HPL Device, Fixation, Ac-Powered, Ophthalmic

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