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510(k) Data Aggregation

    K Number
    K970816
    Device Name
    GLARE WARE
    Manufacturer
    ERGOVISION, INC.
    Date Cleared
    1997-06-05

    (91 days)

    Product Code
    HQY
    Regulation Number
    886.5850
    Type
    Traditional
    Panel
    Ophthalmic
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections. This device is usually available over-the-counter.

    Device Description

    Sunglasses (nonprescription) are devices that consist of spectacle frames or clips with absorbing, reflective, tinted, polarizing, or photosensitized lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

    AI/ML Overview

    The provided text is an FDA 510(k) clearance letter for "GlareWare™ Sunglasses." This document primarily addresses the regulatory approval process and states that the device is substantially equivalent to a predicate device. It does not contain information about acceptance criteria, device performance studies, or details relevant to AI/algorithm performance.

    Therefore, I cannot provide the requested information based on this document. The document confirms market clearance but does not delve into the technical study details you've asked for.

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