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510(k) Data Aggregation

    K Number
    K993487
    Device Name
    PARAGON LENS VIAL
    Manufacturer
    PARAGON VISION SCIENCES
    Date Cleared
    1999-12-22

    (68 days)

    Product Code
    LRX
    Regulation Number
    886.5928
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    K974635
    Predicate For
    K040914
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Paragon Lens Vial is indicated for the chemical disinfection and storage of Rigid Gas Permeable and Hard contact lenses.
    The Paragon Lens Vial is indicated for storage of rigid gas permeable and hard contact lenses during chemical disinfection.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) summary for the Paragon Lens Vial, a contact lens case. It is for chemical disinfection and storage of rigid gas permeable and hard contact lenses. The submission refers to toxicology testing performed to support the premarket notification. However, it does not include information about acceptance criteria or a study proving the device meets said criteria in the format requested.

    The document is a regulatory approval letter and 510(k) summary, which typically outlines the device, its intended use, and its substantial equivalence to a predicate device. While toxicology testing is mentioned, the specifics of an "acceptance criteria and study that proves the device meets the acceptance criteria" in the context of device performance, sample sizes, expert involvement, and ground truth are not present.

    Therefore, I cannot populate the table or answer the specific questions about the study's methodology as the information is not contained within the provided text.

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