886.5850 Sunglasses (nonprescription).§ 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.[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]