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510(k) Data Aggregation

    K Number
    K013467
    Device Name
    TORIC EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) TORIC 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 Toric Eye-Q (Xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia and astigmatism) and presbyopia in aphakic and not-aphakic persons with non-diseased eyes that may exhibit refractive an/or corneal astigmatism up to 5.00 diopters. The lens may be disinfected using a chemical disinfection system.

    Device Description

    Toric Eye-Q (xylofilcon A) Soft (hydrophilic) Toric Multifocal Contact Lens for Daily Wear

    AI/ML Overview

    This document is an FDA 510(k) clearance letter for a contact lens. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the substantial equivalence determination. Therefore, I cannot provide the requested information based on the given text.

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