[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1090]

[Page 470-471]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 886_OPHTHALMIC DEVICES--Table of Contents
 
                      Subpart B_Diagnostic Devices
 
Sec. 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

[[Page 471]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 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]