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510(k) Data Aggregation

    K Number
    K110835
    Device Name
    GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS
    Manufacturer
    GEO MEDICAL CO., LTD.
    Date Cleared
    2012-04-26

    (398 days)

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

    GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens indicated for daily wear to correction of refractive ametropia (myopia and hyperopia) in aphakit and/or not rol ually weat to contection of Formative astigmative astigmatism up to 0.50 dioplers aphakic persons with non discussu eyos the ons is available clear or colored and may be used to enhance or alter the apparent color of the eye.

    Eye care practitioners may prescribe the lens for frequent wear, with cleaning, disinfecting, and scheduled replacement. (see Wearing Schedule).

    Device Description

    GEO Magic Color (polymacon) Soft (hydrophilic) Contact Lens

    AI/ML Overview

    This document is a 510(k) premarket notification approval letter for a contact lens. It does not contain information about the acceptance criteria or a study proving the device meets those criteria. The provided text is primarily administrative correspondence from the FDA to the device manufacturer, confirming substantial equivalence to a legally marketed predicate device.

    Therefore, I cannot extract the requested information based on the provided text.

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