BEUDAMED
    FDA PMA FDA Class 3 30-Day Notice Accepted 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N18033 · Supplement: S114 · Decision Apr 17, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    VISTAKON® (etafilcon A) Brand Contact Lenses
    PMA Number
    N18033
    Supplement Number
    S114
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    30-Day Notice Accepted
    Decision Code
    OK30
    Decision Date
    April 17, 2026
    Date Received
    March 30, 2026
    Supplement Type
    30-Day Notice
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    addition of an alternate raw supplier for subcomponent, Reactive Blue No. 4 (RB4), used in the production of Vistakon (senofilcon A) and Vistakon (etafilcon A) Brand Contact Lenses at the Jacksonville, Florida and Limerick, Ireland manufacturing facilities

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear