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510(k) Data Aggregation

    K Number
    K254052

    Validate with FDA (Live)

    Date Cleared
    2026-02-13

    (58 days)

    Product Code
    Regulation Number
    886.5925
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    DAILIES TOTAL1® (delefilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes with up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

    DAILIES TOTAL1® Multifocal (delefilcon A) soft contact lenses are indicated for the optical correction of presbyopia, with or without refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and who may have up to approximately 1.50 diopters (D) of astigmatism that does not interfere with visual acuity.

    The lenses are to be used for single use, daily disposable wear (less than 24 hours while awake) only. The lenses are not intended to be cleaned or disinfected and should be discarded after a single use.

    Device Description

    DAILIES TOTAL1® (sphere) and DAILIES TOTAL1® Multifocal are soft contact lenses made from delefilcon A lens material. Delefilcon A is a silicone hydrogel material with a water content of approximately 33% and a water gradient surface treatment. The lenses have a light blue tint that makes them easier to see when handling. When hydrated and placed on the cornea, DAILIES TOTAL1® (delefilcon A) soft contact lenses act as a refracting medium to focus light rays on the retina.

    AI/ML Overview

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