[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: 21CFR886.1660]

[Page 477]
 
                        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. 886.1660  Gonioscopic prism.

    (a) Identification. A gonioscopic prism is a device that is a prism 
intended to be placed on the eye to study the anterior chamber. The 
device may have angled mirrors to facilitate visualization of anatomical 
features.
    (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.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
59 FR 63013, Dec. 7, 1994; 66 FR 38812, July 25, 2001]