21 CFR § 886.5810 Ophthalmic Devices

§ 886.5810 Ophthalmic prism reader.

Current through Sep 8, 2026 · Read all of Part 886

(a) Identification. An ophthalmic prism reader is a device intended for use by a patient who is in a supine position to change the angle of print to aid reading.

(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 management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35607, Sept. 14, 1988; 66 FR 38814, July 25, 2001; 90 FR 55993, Dec. 4, 2025]

← § 886.5800 Ophthalmic bar reader. P>(a) Identification. An ophthalmic bar reader is a device that consists of a magnifying lens intended for use by a patient who has impaired vision. The device is placed directly onto reading material to magnify print.§ 886.5820 Closed-circuit television reading system. →