NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS

• K Number: K973016
• Device Name: NORMA KAMLALI/ALFRED SUNG/ROOTS OF CANADA/STEEL MAXX SUNGLASS
• Manufacturer: OPTIMAXX INTL.
• Date Cleared: 1997-09-17 ( 35 days)
• Product Code: HQY
• Regulation Number: 886.5850
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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 does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA to Optimaxx International regarding their "Sunglasses" product, classifying it as substantially equivalent to a predicate device.

Specifically, the document contains:

• A formal letter from the FDA confirming the substantial equivalence of the "Sunglasses" product (K973016) for marketing.
• Information on general controls provisions of the Act for the device.
• The indications for use for the sunglasses, stating they are nonprescription devices intended to protect eyes from bright sunlight but not to provide refractive corrections, and are typically available over-the-counter.

There is no mention of performance metrics, clinical studies, or acceptance criteria within this document.

Regulation Number and Section

§ 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.