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510(k) Data Aggregation

    K Number
    K013469
    Device Name
    EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
    Manufacturer
    SOFLEX CONTACT LENS INDUSTRIES LTD.
    Date Cleared
    2001-11-20

    (33 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

    The Eye-Q (Xylofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 2.00 diopters. The lens may be disinfected using a chemical disinfection system.

    Device Description

    Soflex Eye-Q (Xylofilcon A) Soft (hydrophilic) Multifocal Contact Lens for Daily Wear

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a contact lens. It does not contain information about a study that proves the device meets acceptance criteria, nor does it include details such as sample sizes, ground truth establishment, or expert qualifications. Therefore, I cannot generate the requested table and information about the study.

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