21 CFR 886.1375
§ 886.1375 Bagolini lens.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.1375, § 886.1375 Bagolini lens, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90913
- Permanent ID
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Full text
(a) Identification. A Bagolini lens is a device that consists of a plane lens containing almost imperceptible striations that do not obscure visualization of objects. The device is placed in a trial frame and intended to determine harmonious/anomalous retinal correspondence (a condition in which corresponding points on the retina have the same directional values).
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.