BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lenses, Soft Contact, Daily Wear

    PMA: P830006 · Supplement: S007 · Decision Mar 1, 1994
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135

    Basic Information

    Device Name
    Lenses, Soft Contact, Daily Wear
    Trade Name
    SOFTACT II (POLYMACON)
    PMA Number
    P830006
    Supplement Number
    S007
    Device Class
    FDA Class 2
    Product Code
    LPL
    Generic Name
    Lenses, soft contact, daily wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    March 1, 1994
    Date Received
    January 26, 1994
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Classifications

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

    Product Code Device Name
    LPL Lenses, Soft Contact, Daily Wear