(14 days)
Non-prescription sunglasses are for general use to protect eyes from strong sunlight
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The provided text is a 510(k) premarket notification approval letter from the FDA for "Sunglasses." This type of document is a regulatory approval, not a scientific study describing device performance and acceptance criteria.
Therefore, none of the requested information (acceptance criteria, device performance, study details, sample sizes, expert qualifications, ground truth, etc.) can be extracted from the provided text. The letter simply states that the device (sunglasses) is substantially equivalent to legally marketed predicate devices and can proceed to market.
§ 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.