LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K973526
    Device Name
    SUNGLASSES
    Manufacturer
    PYRAMID HANDBAGS, INC.
    Date Cleared
    1997-10-16

    (28 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 for "Sunglasses" (K973526) from the FDA dated October 16, 1997. It is a regulatory approval document and does not contain information about acceptance criteria or performance studies for the device.

    Specifically, the document states:

    • The device is "substantially equivalent" to predicate devices marketed before May 28, 1976.
    • The indications for use are: "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."

    Therefore, based on the provided text, I cannot answer any of the questions about acceptance criteria or performance studies. This type of information is typically found in the 510(k) submission itself, not the clearance letter.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1