BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P890023 · Supplement: S016 · Decision Sep 24, 2004
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR
    PMA Number
    P890023
    Supplement Number
    S016
    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
    September 24, 2004
    Date Received
    August 18, 2004
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A MINOR DESIGN CHANGE TO INCORPORATE THE ASPHERIC VERSION OF THE LENS; A MINOR EDGE CONFIGURATION CHANGE; AND MINOR LABELING CHANGES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS FOR EXTENDED WEAR AND IS INDICATED AS FOLLOWS: HYDROGENICS 2.0 UV ASPHERE (OCUFILCON F) SOFT (HYDROPHILIC) CONTACT LENS ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NOT-APHAKIC, NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF 2.00 DIOPTERS OR LESS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THEY ARE ALSO INDICATED FOR EXTENDED WEAR UP TO 7 DAYS/6NIGHTS. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE CONTACT LENSES FOR EITHER SINGLE USE DISPOSABLE WEAR OR FOR FREQUENT REPLACEMENT WEAR. WHEN PRESCRIBED FOR FREQUENT REPLACEMENT/ PLANNED REPLACEMENT, THE LENSES MAY BE DISINFECTED USING A CHEMICAL OR HYDROGEN PEROXIDE DISINFECTING SYSTEM. THE DEVICE HELPS PROTECT AGAINST TRANSMISSION OF HARMFUL UV RADIATION TO THE CORNEA AND INTO THE EYE.

    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