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Title 21 Part 886 → Subpart F → §886.5844

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart F → §886.5844

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart F → §886.5844

e-CFR data is current as of August 20, 2019

Title 21Chapter ISubchapter HPart 886Subpart F → §886.5844


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


§886.5844   Prescription spectacle lens.

(a) Identification. A prescription spectacle lens is a glass or plastic device that is a lens intended to be worn by a patient in a spectacle frame to provide refractive corrections in accordance with a prescription for the patient. The device may be modified to protect the eyes from bright sunlight (i.e., prescription sunglasses). Prescription sunglass lenses may be reflective, tinted, polarizing, or photosensitized.

(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 the limitations in §886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 59 FR 63014, Dec. 7, 1994; 66 FR 38814, July 25, 2001]