BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact, Orthokeratology, Overnight

    PMA: P010062 · Supplement: S006 · Decision Feb 21, 2008
    View on FDA
    Classifications
    1
    FEI Numbers
    14
    Registration Numbers
    14

    Basic Information

    Device Name
    Lens, Contact, Orthokeratology, Overnight
    Trade Name
    BOSTON ORTHOKERATOLOGY (OPRIFOCON A) SHAPING LENS FOR OVERNIGHT WEAR FOR BAUSCH & LOMB VISION SHAPING TREATMENT
    PMA Number
    P010062
    Supplement Number
    S006
    Device Class
    FDA Class 3
    Product Code
    NUU
    Generic Name
    Lens, contact, orthokeratology, overnight
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    February 21, 2008
    Date Received
    January 31, 2008
    Supplement Type
    Real-Time Process
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR WET SHIPPING, WITH STORAGE UP TO 30 DAYS, OF THE BOSTON EQUALENS, EQUALENS II AND BOSTON ORTHOKERATOLOGY SHAPING RIGID GAS PERMEABLE CONTACT LENSES IN BOSTON SIMPLUS MULTI-ACTION SOLUTION.

    Classifications

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

    Product Code Device Name
    NUU Lens, Contact, Orthokeratology, Overnight