21 C.F.R. § 886.1090

Current through November 30, 2024
Section 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 .

21 C.F.R. §886.1090

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