BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: N18033 · Supplement: S029 · Decision Oct 7, 1996
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    ACUVUE(R) (ETAFILCON A) EXTENDED WEAR CONTACT LENS (CLEAR AND TINTED WITH UV BLOCKER)
    PMA Number
    N18033
    Supplement Number
    S029
    Device Class
    FDA Class 3
    Product Code
    LPM
    Generic Name
    Lenses, soft contact, extended wear
    Regulation Number
    886.5925
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    October 7, 1996
    Date Received
    July 18, 1996
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Process Change - Manufacturer/Sterilizer/Packager/Supplier
    Expedited Review
    N

    Advisory Committee Statement

    ADDITION OF A UV BLOCKER, NORBLOC(R) 7966, TO THE APPROVED MOLDED ETAFILCON A EXTENDED WEAR CONTACT LENS (CLEAR AND WITH VISIBILITY TINT), AND A MULTI-FOCAL DESIGN WHICH WAS REVIOUSLY CLEARED FOR THE DAILY WEAR ETAFILCON A LENS UNDER K953804

    Classifications

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

    Product Code Device Name
    LPM Lenses, Soft Contact, Extended Wear