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510(k) Data Aggregation

    K Number
    K983021
    Device Name
    METROSOFT II, METROSOFT TORIC, METROLITE, METROTINT, SATUREYES, SATUREYES TORIC, SATUREYES LITE, SATUREYES LITE TORIC
    Manufacturer
    METROSOFT, INC.
    Date Cleared
    1998-11-13

    (74 days)

    Product Code
    LPL
    Regulation Number
    886.5925
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    METROSOFT, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    MetroSoft II, MetroTint and MetroLite contact lens are indicated for daily wear for the correction of visual acuity in aphakic or non-aphakic persons with non-diseased eyes who may have 1.50 diopters or less of astigmatism that does not interfere with visual acuity. The lens power range is -20.00 diopters to +20.00 diopters.

    MetroSoft Toric contact lens for daily wear are indicated for use by patients with non-diseased eyes who are not aphakic or aphakic and who have refractive and/or corneal astigmatism of up to 6.00 diopters and require powers from -20.00 to +20.00 diopters.

    SaturEyes spherical (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myonia or hyperopia and astigmatism of up to 1.5 Diopters where the astigmatism does not interfere with visual acuity.

    SaturEyes Toric (hioxyfilcon A) soft (hydrophilic) contact lenses for daily wear are indicated for the correction of visual acuity in non aphakic persons with non-diseased eyes with myopia or hyperopia and corneal astigmatism of up to 4.00 Diopters or less where the astigmatism does not interfere with visual acuity.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for contact lenses and does not contain information about the acceptance criteria or a study that proves a device meets those criteria for an AI/ML medical device.

    Therefore, I cannot provide the requested information.

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