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Title 21 Part 886 → Subpart F → §886.5840

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart F → §886.5840

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart F → §886.5840

e-CFR data is current as of July 15, 2019

Title 21Chapter ISubchapter HPart 886Subpart F → §886.5840


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


§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.

[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]