[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1250]

[Page 443]
 
                        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. 886.1250  Euthyscope.

    (a) Identification. A euthyscope is a device that is a modified AC-
powered or battery-powered ophthalmoscope (a perforated mirror device 
intended to inspect the interior of the eye) that projects a bright 
light encompassing an arc of about 30 degrees onto the fundus of the 
eye. The center of the light bundle is blocked by a black disk covering 
the fovea (the central depression of the macular retinae where only 
cones are present and blood vessels are lacking). The device is intended 
for use in the treatment of amblyopia (dimness of vision without 
apparent disease of the eye).
    (b) Classification. Class I for the battery powered device. The 
battery powered 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. Class II for the AC-powered device.

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