BEUDAMED
    FDA PMA FDA Class 2 Approved (Withdrawn) 🇺🇸 United States

    Lenses, Soft Contact, Daily Wear

    PMA: P850072 · Decision Jul 17, 1986
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135

    Basic Information

    Device Name
    Lenses, Soft Contact, Daily Wear
    Trade Name
    DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
    PMA Number
    P850072
    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    Approved (Withdrawn)
    Decision Code
    APWD
    Decision Date
    July 17, 1986
    Date Received
    September 30, 1985
    Expedited Review
    N
    Docket Number
    86M-0325

    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