![]() |
Code of Federal Regulations (Last Updated: May 6, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter H - Medical Devices |
![]() |
Part 886 - Ophthalmic Devices |
![]() |
Subpart F - Therapeutic Devices |
§ 886.5870 - Low-vision telescope.
-
§ 886.5870 Low-vision telescope.
(a) Identification. A low-vision telescope is a device that consists of an arrangement of lenses or mirrors intended for use by a patient who has impaired vision to increase the apparent size of objects. This generic type of device includes handheld or spectacle telescopes.
(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. The device is also exempt from the current good manufacturing practice requirements of the quality system regulation in part 820 of this chapter, with the exception of § 820.180, with respect to general requirements concerning records, and § 820.198, with respect to complaint files.
[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001]