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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
OP
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.

§ 886.5850 Sunglasses (nonprescription).

(a)
Identification. 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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9.