[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: 21CFR886.1420]

[Page 455-456]
 
                        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. 886.1420  Ophthalmic lens gauge.

    (a) Identification. An ophthalmic lens gauge is a calibrated device 
intended to manually measure the curvature of a spectacle lens.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in

[[Page 456]]

subpart E of part 807 of this chapter, subject to the limitations in 
Sec. 886.9.

[52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 
66 FR 38811, July 25, 2001]