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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.

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 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.

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