BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lens, Contact, Orthokeratology, Overnight

    PMA: P010062 · Supplement: S002 · Decision Dec 3, 2004
    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 BAUSH & LOMB VISION SHAPING TREATMENT
    PMA Number
    P010062
    Supplement Number
    S002
    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
    December 3, 2004
    Date Received
    September 1, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL TO REVISE THE PROFESSIONAL FITTING AND INFORMATION GUIDE PRODUCT LABELING TO INCLUDE FITTING GUIDELINES FOR CORNEAL TOPOGRAPHY-BASED FITTING METHODS AND OTHER MINOR CHANGES AND GRAMMATICAL CORRECTIONS. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE SAME PRIOR APPROVED INDICATIONS FOR USE.

    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