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510(k) Data Aggregation

    K Number
    K251095
    Date Cleared
    2025-09-17

    (160 days)

    Product Code
    Regulation Number
    886.5925
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Sphere and Asphere
      Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Sphere and Asphere designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

    • Toric
      Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Toric designs are indicated for daily wear for the correction of refractive ametropia (myopia or hyperopia with astigmatism) in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and astigmatic corrections from -0.50 to -3.50 diopters.

    • Multifocal
      Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses with Multifocal designs are indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic and/or non-aphakic persons with non-diseased eyes in powers from +6.00 to -12.00 diopters and with non-diseased eyes who may require a reading addition from +0.25D to +3.00D. The lenses may be worn by persons who exhibit astigmatism of 1.00 diopters or less that does not interfere with visual acuity.

    The lenses are intended for single-use disposable wear.

    Device Description

    The Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses are visibility-tinted and include UV blocker-containing materials. The lens is available in sphere, asphere, toric and multifocal designs. It is a non-ionic hydrogel lens derived from Hioxifilcon A material which is a co-polymer of 2-Hydroxyethyl methacrylate (HEMA) and 2,3-Dihydroxypropyl methacrylate (Glycerol methacrylate, GMA), cross-linked with Ethylene glycol dimethacrylate (EGDMA) and made by photo-polymerization. It consists of 41% Hioxifilcon A and 59% water by weight when immersed in buffered solution. There are two types of buffer solution, one is borate solution another one is borate solution with Tween 80, Hyaluronic Acid and Polyethylene Glycol. The lens further contains a benzotriazole UV absorbing monomer and thus is able to block UV radiation. The lens is visibly tinted with "Reactive Blue 19", "Reactive Red 180", and "Reactive Yellow 15", which are approved color additives by the U.S. FDA and listed in 21 CFR part 73.3121. The UV Blocking averages 95% in the UVB range of 280 nm to 315 nm and 50% in the UVA range of 315 nm to 380 nm. The Hioxifilcon A name has been adopted by the United States Adopted Names Council (USAN).

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