BEUDAMED
    FDA PMA Approved 🇺🇸 United States

    PMA: P960022 · Supplement: S013 · Decision Apr 8, 2025
    View on FDA
    Classifications
    0
    FEI Numbers
    0
    Registration Numbers
    0

    Basic Information

    Trade Name
    SofLens® Toric (alphafilcon A) Visibility Tinted Contact Lenses
    PMA Number
    P960022
    Supplement Number
    S013
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    April 8, 2025
    Date Received
    January 31, 2025
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    Approval for minor changes to the finished product specification for Soflens Toric (alphafilcon A) Visibility Tinted Contact Lenses.