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

    FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C

    K Number: K991780 · Decision Jun 29, 1999
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    2
    Review Days
    35

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    Basic Information

    Device Name
    FLUOREX 700 -UV (FLUSILFOCON A), FLUOREX 500-UV (FLUSILFOCON B) AND FLUOREX 300-UV (FLUSILFOCON C) RIGID GAS PERMEABLE C
    K Number
    K991780
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    G.T. Laboratories, Inc.
    Date Received
    May 25, 1999
    Decision Date
    June 29, 1999
    Product Code
    HQD
    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
    HQD Lens, Contact (Other Material) - Daily

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    Other Clearances by G.T. Laboratories, Inc.

    K Number Device Name
    K991781 FLUOREX ULTRA (FLUSILFOCON E) RIGID GAS PERMEABLE CONTACT LENS