BEUDAMED
    FDA PMA FDA Class 3 Approved 🇺🇸 United States

    Lenses, Soft Contact, Extended Wear

    PMA: P830037 · Supplement: S045 · Decision May 1, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    56
    Registration Numbers
    56

    Basic Information

    Device Name
    Lenses, Soft Contact, Extended Wear
    Trade Name
    FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES FOR EXTENDED WEAR UP TO 7 DAYS/
    PMA Number
    P830037
    Supplement Number
    S045
    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
    May 1, 2002
    Date Received
    March 28, 2002
    Supplement Type
    Real-Time Process
    Supplement Reason
    Change Design/Components/Specifications/Material
    Expedited Review
    N

    Advisory Committee Statement

    APPROVAL FOR A CHANGE OF TINT FROM PHTHALOCYANINE GREEN TO CARBAZOLE VIOLET FOR FRESHLOOK SPHERICAL, TORIC AND BIFOCAL (PHEMFILCON A) UV SOFT (HYDROPHILIC) CONTACT LENSES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME REFERENCED ABOVE WITH THE FOLLOWING INDICATION: FRESHLOOK SPHERICAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 2.0 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. FRESHLOOK TORIC (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO 6.0 DIOPTERS. FRESHLOOK BIFOCAL (PHEMFILCON A) SOFT (HYDROPHILIC) CONTACT LENSES ARE INDICATED FOR THE CORRECTION OF VISUAL ACUITY AND PRESBYOPIA IN PERSONS WITH NON-DISEASED EYES THAT ARE MYOPIC (NEARSIGHTED) OR HYPEROPIC (FARSIGHTED) AND MAY EXHIBIT REFRACTIVE ASTIGMATISM OF UP TO .75 DIOPTERS THAT DOES NOT INTERFERE WITH VISUAL ACUITY. THE LENSES MAY BE PRESCRIBED FOR EXTENDED WEAR IN NOT-APHAKIC PERSONS FROM 1-7 DAYS BETWEEN REMOVAL FOR CLEANING AND DISINFECTION OR DISPOSAL, AS RECOMMENDED BY THE EYE CARE PRACTITIONER. THE EYE CARE PRACTITIONER MAY PRESCRIBE THE LENS IN EITHER A SINGLE USE DISPOSABLE PROGRAM OR IN A FREQUENT REPLACEMENT PROGRAM WITH CLEANING, DISINFECTION, AND SCHEDULED REPLACEMENT. WHEN PRESCRIBED IN A FREQUENT REPLACEMENT PROGRAM, THE LENS MAY BE DISINFECTED USING A CHEMICAL (HOT HEAT) DISINFECTION SYSTEM. FRESHLOOK LENSES WITH UV ABSORBING MONOMER HELP 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