[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: 21CFR886.1050]

[Page 433]
 
                        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. The device is exempt from the premarket 
notification procedures in subpart E of part 807 of this chapter.

[55 FR 48441, Nov. 20, 1990, as amended at 59 FR 63012, Dec. 7, 1994]

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