21 C.F.R. § 886.5840

Current through October 31, 2024
Section 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 .

21 C.F.R. §886.5840

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