CFR > Title 21 - Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES (parts 800 to 898) > PART 886—OPHTHALMIC DEVICES > SUBPART F—Therapeutic Devices (§886.5100 to §886.5933) > 886.5840—Magnifying spectacles.

886.5840—Magnifying spectacles.

(a) Identification. Magnifying spectacles are devices that consist of spectacle frames with convex lenses intended to be worn by a patient who has impaired vision to enlarge images.
(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 § 866.9.

Code of Federal Regulations

[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]