BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Intraocular Lens

    PMA: P100016 · Supplement: S001 · Decision May 28, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    59
    Registration Numbers
    59

    Basic Information

    Device Name
    Intraocular Lens
    Trade Name
    AARIS AND AARIS WITH ADAPTIV OPTICS INTRAOCULAR LENS
    PMA Number
    P100016
    Supplement Number
    S001
    Device Class
    FDA Class 3
    Product Code
    HQL
    Generic Name
    intraocular lens
    Regulation Number
    886.3600
    Medical Specialty
    Ophthalmic
    Advisory Committee
    Ophthalmic
    Decision
    Approved
    Decision Code
    APPR
    Decision Date
    May 28, 2013
    Date Received
    February 19, 2013
    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 A CHANGE TO THE TRADE NAME OF THE APPROVED LENSES AND LABELING CHANGES TO THE UNIT CARTON, INCLUDING A CHANGE TO THE COLOR SCHEME AND FORMAT. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME AARIS ACRYLIC INTRAOCULAR LENS (IOL), MODELS EC-3 AND EC-3 PRECISION ASPHERIC LENS (PAL) AND IS INDICATED FOR PRIMARY IMPLANTATION IN THE CAPSULAR BAG OF THE EYE FOR THE VISUAL CORRECTION OF APHAKIA IN ADULT PATIENTS IN WHOM A CATARACTOUS LENS HAS BEEN REMOVED.

    Classifications

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

    Product Code Device Name
    HQL Intraocular Lens