[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR886.1450]

[Page 438-439]
 
                        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. 886.1450  Corneal radius measuring device.

    (a) Identification. A corneal radius measuring device is an AC-
powered device intended to measure corneal size by superimposing the 
image of the cornea on a scale at the focal length of the lens of a 
small, hand held, single tube penscope or eye gauge magnifier.
    (b) Classification. Class I. The device is exempt from the premarket 
notification procedures in subpart E of part 807

[[Page 439]]

of this chapter only when the device does not include computer software 
in the unit or topographers.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994]