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510(k) Data Aggregation

    K Number
    K023732
    Device Name
    CIBASOFT PROGRESSIVE TORIC (TEFILCON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
    Manufacturer
    CIBA VISION CORPORATION
    Date Cleared
    2002-12-10

    (34 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    CIBASOFT® PROGRESSIVE TORIC (tefilcon) soft (hydrophilic) contact lenses are indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in aphakic or not aphakic persons with non-diseased eyes. The lenses may be worn by persons who have 0.75 to 2.75 diopters of refractive and/or corneal astigmatism that does not interfere with visual acuity.

    Device Description

    CIBASCIFT® PROGRESSIVE TORIC soft contact lenses are hemispherical flexible shells maade of tefilcon, a hydrophilic polymer of hydroxyethylmethacrylate (HEMA), with a water content of 37,5% by weight in normal saline solution. The lens is available in 8.6mm and 8.9mm base curves, 14.5mm diameter with center thickness of 0.012mm at -3.00 dioxoters or 0.014mm at +3.00 diopters, and powers ranges from -25.00 to +25.00cicopters. CIBASOFT® PROGRESSIVE TORIC has a toric optic zone on its front surface with a centermost aspheric zone on its back surface. This aspheric zone has an add poweer range from 0.25 to 0.75 diopters for vision correction at near. For optimum stabilizatition of the lens on the cornea, there are two thin zones on the front surface at the 12 o'clock and 6 o'clock positions.

    AI/ML Overview

    The provided text does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) premarket notification summary for the CIBASOFT® PROGRESSIVE TORIC Soft (hydrophilic) Contact Lens, focusing on its substantial equivalence to a predicate device.

    Specifically, the text states:

    • "The addition of the multifocal or presbyopic feature to the centermost part of opptical zone of the base curve, does not raise new safety or efficacy issues, thus, CIBASQ5FT® PROGRESSIVE TORIC is substantially equivalent to the TORISOFT® lens."

    This indicates that the manufacturer is relying on the established safety and efficacy of the predicate device (TORISOFT® Soft (hydrophilic) Contact Lens, PMA #810005), arguing that the modifications made to the CIBASOFT® PROGRESSIVE TORIC lens do not introduce new safety or effectiveness concerns that would require a new, independent study with specific acceptance criteria.

    Therefore, I cannot provide the requested information as it is not present in the given document.

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