[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1290]

[Page 453]
 
                        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. 886.1290  Fixation device.

    (a) Identification. A fixation device is an AC-powered device 
intended for use as a fixation target for the patient during 
ophthalmological examination. The patient directs his or her gaze so 
that the visual image of the object falls on the fovea centralis (the 
center of the macular retina of the eye.)
    (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 Sec. 886.9.

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