[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: 21CFR886.1270] [Page 472] 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. 886.1270 Exophthalmometer. (a) Identification. An exophthalmometer is a device, such as a ruler, gauge, or caliper, intended to measure the degree of exophthalmos (abnormal protrusion of the eyeball). (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. [52 FR 33355, Sept. 2, 1987, as amended at 53 FR 35604, Sept. 14, 1988; 66 FR 38810, July 25, 2001]