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    K Number
    K250364
    Device Name
    Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
    Manufacturer
    St. shine Optical Co., Ltd.
    Date Cleared
    2025-10-07

    (239 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K240477
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia) in aphakic or not-aphakic persons with non-diseased eyes who may have 1.00D of astigmatism or less does not interfere with visual acuity.

    Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia, hyperopia, and astigmatism) in aphakic or not-aphakic persons with non-diseased eyes. The toric lens is specified for up to 3.00 diopters of astigmatism. The highest cylinder power is -3.00D.

    Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is indicated for daily wear for the correction of refractive ametropia (myopia and hyperopia) and presbyopia in aphakic or not-aphakic persons with non- diseased eyes who may have 0.75D of astigmatism or less does not interfere with visual acuity. The multi-focal lens is specified for up to +3.00 diopters of add power. The highest add power is +3.00D.

    Saview SH Optic 38 UV, Saview SH Optic 38 UV toric, and Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens is daily disposable wear. Eye care practitioners may prescribe the lens for daily disposable wear. The lens may be prescribed for single-use daily disposable wear and not intended to be cleaned or disinfected and should be discarded after a single use.

    Device Description

    The lens designs include spherical, toric and multifocal lenses.
    UV absorbing monomer is used. The transmittance are less than 5% in the UVB range of 280-315nm and less than 50% in the UVA range of 316-380nm.
    Tinted blue [Phthalocyaninato(2-)] copper in color additives approved in 21 CFR Part 74 for use in medical device is used.
    The lens contains 38% water by weight and each lens is supplied sterile in a blister container in saline solution with PEG.

    AI/ML Overview

    N/A

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