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Title 21 Part 886 → Subpart B → §886.1090

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1090

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1090

e-CFR data is current as of June 19, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1090


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


§886.1090   Haidinger brush.

(a) Identification. A Haidinger brush is an AC-powered device that provides two conical brushlike images with apexes touching which are viewed by the patient through a Nicol prism and intended to evaluate visual function. It may include a component for measuring macular integrity.

(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.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 66 FR 38810, July 25, 2001; 72 FR 17400, Apr. 9, 2007]