[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: 21CFR886.1500]

[Page 476]
 
                        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. 886.1500  Headband mirror.

    (a) Identification. A headband mirror is a device intended to be 
strapped to the head of the user to reflect light for use in examination 
of the eye.
    (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. The device is 
also exempt from the current good manufacturing practice regulations in 
part 820 of this chapter, with the exception of Sec. 820.180, with 
respect to general requirements concerning records, and Sec. 820.198, 
with respect to complaint files.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35605, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]