BEUDAMED
    FDA PMA FDA Class 2 Approved 🇺🇸 United States

    Lenses, Soft Contact, Daily Wear

    PMA: N17752 · Supplement: S037 · Decision Sep 18, 2000
    View on FDA
    Classifications
    1
    FEI Numbers
    135
    Registration Numbers
    135

    Basic Information

    Device Name
    Lenses, Soft Contact, Daily Wear
    Trade Name
    SOFTMATE II, HYDROCURVE II, AND HYDROCURVE II APHAKIC (BUFILCON A)
    PMA Number
    N17752
    Supplement Number
    S037
    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
    September 18, 2000
    Date Received
    December 23, 1999
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Express GMP Supplement
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE MANUFACTURING FACILITY LOCATED AT WESLEY JESSEN, INC., CIDRA, PUERTO RICO.

    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