BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P860022 · Decision Nov 30, 1987
    View on FDA
    Classifications
    1
    FEI Numbers
    16
    Registration Numbers
    16

    Basic Information

    Device Name
    Lens, Contact (Rigid Gas Permeable), Extended Wear
    Trade Name
    BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
    PMA Number
    P860022
    Device Class
    FDA Class 3
    Product Code
    MWL
    Generic Name
    Lens, contact (rigid gas permeable), extended wear
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    November 30, 1987
    Date Received
    June 2, 1986
    Expedited Review
    N
    Docket Number
    87M-0395

    Classifications

    This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MWL Lens, Contact (Rigid Gas Permeable), Extended Wear