BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact (Rigid Gas Permeable), Extended Wear

    PMA: P860022 · Supplement: S056 · Decision May 30, 2006
    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 (ITAFLUOROFOCON A AND OPRIFOCON A)
    PMA Number
    P860022
    Supplement Number
    S056
    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
    May 30, 2006
    Date Received
    January 27, 2006
    Supplement Type
    135 Review Track For 30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF A COLD OXYGEN PLASMA TREATMENT STEP TO THE CURRENT MANUFACTURING PROCESS FOR THE BOSTON EQUALENS (ITAFLUOROFOCON A), BOSTON EQUALENS II, AND BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS

    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