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510(k) Data Aggregation

    K Number
    K242059
    Device Name
    Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A)
    Manufacturer
    X-Cel Specialty Contacts, A Walman Optical Company
    Date Cleared
    2024-08-14

    (30 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Why did this record match?
    Applicant Name (Manufacturer) :

    X-Cel Specialty Contacts, A Walman Optical Company

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Flexlens sphere (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic persons with non-diseased eyes. The lens may be worn by persons who exhibit refractive astigmatism of 0.75 diopters or less where the astigmatism does not interfere with visual acuity. The Flexlens toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia and hyperopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 12 diopters. The Flexlens multifocal (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myperopia) in aphakic and non-aphakic persons with non-diseased eyes and or possesses refractive astigmatism not exceeding 0.75 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Flexlens multifocal toric (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons with non-diseased eyes and/or possesses refractive astigmatism not exceeding 4 diopters and are presbyopic requiring add power of up to +4.00 diopters. The Flexlens irregular cornea (efrofilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lenses for daily wear are indicated for the correction of ametropia (myopia) in aphakic and non-aphakic persons and may be prescribed in otherwise non-diseased eyes that require a Soft Contact Lens for the management of irregular corneal conditions such as keratoconus and post graft fitting. Eyecare practitioners may prescribe the lenses for frequent/planned replacement wear, with cleaning, disinfection, and scheduled replacement. When prescribed for frequent wear, the lens may be cleaned and disinfected using a chemical (not heat) lens care system or hydrogen peroxide disinfection systems.
    Device Description
    The Flexlens Silicone Hydrogel Daily Wear Soft (Hydrophilic) Contact Lens (efrofilcon A) are fabricated from efrofilcon A. which in the dry (unhydrated) state may be machined and polished. The hydrophilic nature of this material allows the lens to become soft and pliable when immersed in an aqueous solution. The non-ionic lens material, (efrofilcon A) is a daily wear silicone hydrogel contact lens that is not surface treated and characterized by a high water content. The lens material is composed of silicone monomers cross linked with other monomers and optionally incorporates RB246 (1,4-Bis[4-(2-Methacryloxyethy]) phenylamino]-9, 10-Anthraquinone) as an integrated handling tint. The lenses are made by lathe-cut for individual patients. It consists of 26% efrofilcon A and 74% water by weight when immersed in a buffered saline solution. The (efrofilcon A) name has been adopted by the United States Adopted Names Council (USAN). In the hydrated state, the lens conforms to the curvature of the eye covering the cornea and extending slightly beyond the limbus forming a colorless, transparent optical surface. The (efrofilcon A) soft hydrophilic contact lens has a spherical back surface. The hydrophilic properties of the lens require that it be maintained in a fully hydrated state in a solution compatible with the eye. If the lens dries out, it will become hard appear somewhat warped however, it will return to its proper configuration when completely rehydrated in the proper storage solution.
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