21 CFR § 886.1880 Ophthalmic Devices

§ 886.1880 Fusion and stereoscopic target.

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

(a) Identification. A fusion and stereoscopic target is a device intended for use as a viewing object with a stereoscope (§ 886.1870).

(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 35606, Sept. 14, 1988; 66 FR 38813, July 25, 2001; 90 FR 55991, Dec. 4, 2025]

← § 886.1870 Stereoscope.§ 886.1905 Nystagmus tape. →