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

    LENS-EZE

    K Number: K862094 · Decision Jun 19, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    27
    Registration Numbers
    27
    Same Product Code
    40
    Applicant Total
    2
    Review Days
    17

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    Basic Information

    Device Name
    LENS-EZE
    K Number
    K862094
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1385
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Insight International, Inc.
    Date Received
    June 2, 1986
    Decision Date
    June 19, 1986
    Product Code
    HJK
    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
    HJK Lens, Contact, Polymethylmethacrylate, Diagnostic

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