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Title 21 Part 886 → Subpart B → §886.1375

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1375

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1375

e-CFR data is current as of June 13, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1375


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§886.1375   Bagolini lens.

(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 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 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001]