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Title 21 Part 886 → Subpart B → §886.1450

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart B → §886.1450

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart B → §886.1450

e-CFR data is current as of August 21, 2019

Title 21Chapter ISubchapter HPart 886Subpart B → §886.1450


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart B—Diagnostic Devices


§886.1450   Corneal radius measuring device.

(a) Identification. A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier.

(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 §886.9, only when the device does not include computer software in the unit or topographers.

[55 FR 48442, Nov. 20, 1990, as amended at 59 FR 63013, Dec. 7, 1994; 66 FR 38811, July 25, 2001]