21 CFR 886.1090 - Haidinger brush.

Regulations last checked for updates: Oct 17, 2024

Title 21 - Food and Drugs last revised: Oct 15, 2024

View all text of Subpart B [§ 886.1040 - § 886.1945]

§ 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]

authority: 21 U.S.C. 351,360,360c,360e,360j,360

source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.

cite as: 21 CFR 886.1090