§886.5850. Sunglasses (nonprescription).
21 C.F.R. § 886.5850
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
Amendments
[52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]