BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P080011 · Supplement: S035 · Decision Mar 11, 2015
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, BIOFINITY XR MULTIFOCAL
    PMA Number
    P080011
    Supplement Number
    S035
    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
    March 11, 2015
    Date Received
    December 16, 2014
    Supplement Type
    Normal 180 Day Track
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE IN TRADE NAME FOR THE BIOFINITY ENERGYS ASPHERIC LENS AND EXPANDED POWERS FOR THE BIOFINITY XR TORIC AND BIOFINITY XR MULTIFOCAL LENSES. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES BIOFINITY ENERGYS ASPHERE, BIOFINITY XR TORIC, AND BIOFINITY XR MULTIFOCAL (COMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOREXTENDED WEAR AND ARE INDICATED FOR: BIOFINITY ENERGYS ASPHERE (COMFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA AND HYPEROPIA) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 DIOPTERS. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBIT ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.BIOFINITY XR TORIC (COMFILCON A) SOFT CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF AMETROPIA (MYOPIA OR HYPEROPIA WITH ASTIGMATISM) IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 D AND ASTIGMATISM CORRECTIONS FROM -0.25 TO -5.75 D.BIOFINITY XR MULTIFOCAL (COMFILCON A) LENSES ARE INDICATED FOR THE CORRECTION OF REFRACTIVE AMETROPIA (MYOPIA AND HYPEROPIA) WITH EMMETROPIA WITH PRESBYOPIA IN APHAKIC AND NON-APHAKIC PERSONS WITH NON-DISEASED EYES IN POWERS FROM -20.00 TO +20.00 D AND WITH ADD POWERS FROM +0.05 TO +4.00 D. THE LENSES MAY BE WORN BY PERSONS WHO EXHIBITASTIGMATISM OF 2.00 D OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY.

    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