BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P980006 · Supplement: S022 · Decision Jul 11, 2014
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    BAUSCH & LOMB PUREVISION2 (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES, BASUCH & LOMB PUREVISION2 MULTI-FOCAL (BALAFI
    PMA Number
    P980006
    Supplement Number
    S022
    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
    July 11, 2014
    Date Received
    April 14, 2014
    Supplement Type
    Normal 180 Day Track No User Fee
    Supplement Reason
    Labeling Change - Indications/instructions/shelf life/tradename
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR THE ADDITION OF THE FOLLOWING PRIVATE LABEL TRADE NAMES: EQUATE MONTHLY SINGLE VISION (BALAFILCON A) CONTACT LENS, EQUATE MONTHLY MULTI-FOCAL (BALAFILCON A) CONTACT LENS, EQUATE MONTHLY TORIC (BALAFILCON A) CONTACT LENSES, AND C-VUE ADDVANTAGE MULTIFOCAL (BALAFILCON A) VISIBILITY TINTED CONTACT LENSES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME THE EQUATE MONTHLY SINGLE VISION (BALAFILCON A) CONTACT LENS AND IS INDICATED FOR DAILY WEAR OR EXTENDED WEAR FROM 1 TO 30 DAYS BETWEEN REMOVALS, FOR CLEANING AND DISINFECTION OR DISPOSAL OF THE LENS, AS RECOMMENDED BYTHE EYE CARE PROFESSIONAL. THE LENS IS INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND/OR NOT-APHAKIC PERSONS WITH NON-DISEASED EYES, EXHIBITING ASTIGMATISM OF 2.00 DIOPTERS OR LESS, THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENS MAY BE PRESCRIBED FOR FREQUENT/PLANNED REPLACEMENT WEAR OR DISPOSABLE WEAR IN SPHERICAL POWERS RANGING FROM +8.00D TO -20.00D WHEN PRESCRIBED FOR UP TO 30 DAYS OF EXTENDED WEAR AND FROM +20.00D TO -20.00D FOR DAILY WEAR OR EXTENDED WEAR UP TO 7 DAYS.FOR FURTHER INFORMATION PLEASE REFER TO THE APPROVAL ORDER.

    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