BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lenses, Soft Contact, Daily Wear

    PMA: P940013 · Supplement: S005 · Decision Oct 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135

    Basic Information

    Device Name
    Lenses, Soft Contact, Daily Wear
    Trade Name
    PRECISION(TM) UV (VASURFILCON)
    PMA Number
    P940013
    Supplement Number
    S005
    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
    October 7, 1996
    Date Received
    April 4, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE TINTING OF THE DEVICE WITH AN ALTERNATE, NON-REACTIVE, LIGHT BLUE-GREEN LOCATOR TINT (D&C GREEN NO. 6, C.I. NO. 61565) USING AN IN-MONOMER TINTING PROCESS FOR THE PRECISION(TM) UN (VASURFILCON A) HYDROPHILIC CONTACT LENS FOR EXTENDED WEAR

    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