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510(k) Data Aggregation

    K Number
    K974861
    Device Name
    NON-PRESCRIPTION SUNGLASSES
    Manufacturer
    WENZHOU HINDAR OPTICAL CO., LTD.
    Date Cleared
    1998-01-27

    (29 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 photosenstitzed 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 photosenstitzed lenses intended to be worn by a person to protect the eyes from bright sunlight but not to provide refractive corrections.

    AI/ML Overview

    This document is a 510(k) clearance letter for "Non-prescription Sunglasses". It does not contain information about acceptance criteria or a study proving that the device meets acceptance criteria. The letter primarily confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed.

    Therefore, I cannot extract the requested information from the provided text.

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