[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: 21CFR886.1350]

[Page 453-454]
 
                        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. 886.1350  Keratoscope.

    (a) Identification. A keratoscope is an AC-powered or battery-
powered device intended to measure and evaluate the corneal curvature of 
the eye. Lines and

[[Page 454]]

circles within the keratoscope are used to observe the corneal reflex. 
This generic type of device includes the photokeratoscope which records 
corneal curvature by taking photographs of the cornea.
    (b) The device is exempt from the premarket notification procedures 
in subpart E of part 807 of this chapter subject to Sec. 886.9. The 
battery-powered device is exempt from the current good manufacturing 
practice regulations in part 820 of this chapter, with the exception of 
Sec. 820.180 of this chapter, with respect to general requirements 
concerning records, and Sec. 820.198 of this chapter, with respect to 
complaint files

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994; 65 
FR 2320, Jan. 14, 2000]