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510(k) Data Aggregation

    K Number
    K972490
    Device Name
    D'ARC EYE CARE SUNGLASSES
    Manufacturer
    M & R DIST.
    Date Cleared
    1997-07-25

    (23 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

    This document is a 510(k) clearance letter from the FDA for "D'Arc Eye Care System Sunglasses." It primarily focuses on regulatory approval rather than technical performance studies. There is no information provided regarding acceptance criteria or a study proving the device meets them.

    Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria, as this information is not present in the provided text. The document is strictly a regulatory approval notice, stating the device is substantially equivalent to legally marketed predicate devices.

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