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

    OPTI-FREE EXPRESS LENS DROPS

    K Number: K000385 · Decision Apr 28, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    25
    Registration Numbers
    25
    Same Product Code
    32
    Applicant Total
    5
    Review Days
    81

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    Basic Information

    Device Name
    OPTI-FREE EXPRESS LENS DROPS
    K Number
    K000385
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5918
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Alcon Universal, Ltd.
    Date Received
    February 7, 2000
    Decision Date
    April 28, 2000
    Product Code
    MRC
    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
    MRC Products, Contact Lens Care, Rigid Gas Permeable

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    Other Clearances by Alcon Universal, Ltd.

    K Number Device Name
    K021143 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
    K002589 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
    K001214 OPTI-FREE EXPRESS MULTI-PURPOSE DISINFECTING SOLUTION
    K001235 OPTI-FREE SUPRACLENS DAILY POTEIN REMOVER / RGP MULTI-PURPOSE DISINFECTING SOLUTION ID 100136