[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: 21CFR886.1050]

[Page 470]
 
                        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. 886.1050  Adaptometer (biophotometer).

    (a) Identification. An adaptometer (biophotometer) is an AC-powered 
device that provides a stimulating light source which has various 
controlled intensities intended to measure the time required for retinal 
adaptation (regeneration of the visual purple) and the minimum light 
threshold.
    (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 38809, July 25, 2001]