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510(k) Data Aggregation

    K Number
    K974852

    Validate with FDA (Live)

    Device Name
    NON-PRESCRIPTION SUNGLASSES
    Manufacturer
    CHIA HUI SPECTACLES MFG. CORP.
    Date Cleared
    1998-01-30

    (32 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

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain any information about acceptance criteria, device performance, or any studies conducted. The document is an FDA 510(k) clearance letter for "Non-prescription Sunglasses," indicating that the device has been found substantially equivalent to a predicate device. It discusses regulatory matters such as marketing authorization, general controls, and compliance with regulations, but does not include any performance data or study details.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given text.

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