[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: 21CFR886.1340]

[Page 473]
 
                        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. 886.1340  Haploscope.

    (a) Identification. A haploscope is an AC-powered device that 
consists of two movable viewing tubes, each containing a slide carrier, 
a low-intensity light source for the illumination of the slides, and a 
high-intensity light source for creating afterimages. The device is 
intended to measure strabismus (eye muscle imbalance), to assess 
binocular vision (use of both eyes to see), and to treat suppression and 
amblyopia (dimness of vision without any apparent disease 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]