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Title 21 Part 886 → Subpart F → §886.5850

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart F → §886.5850

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart F → §886.5850

e-CFR data is current as of September 13, 2019

Title 21Chapter ISubchapter HPart 886Subpart F → §886.5850


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart F—Therapeutic Devices


§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]