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Title 21 Part 886 → Subpart E → §886.4070

Title 21 → Chapter I → Subchapter H → Part 886 → Subpart E → §886.4070

Electronic Code of Federal Regulations e-CFR

Title 21 Part 886 → Subpart E → §886.4070

e-CFR data is current as of June 13, 2019

Title 21Chapter ISubchapter HPart 886Subpart E → §886.4070


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices


§886.4070   Powered corneal burr.

(a) Identification. A powered corneal burr is an AC-powered or battery-powered device that is a motor and drilling tool intended to remove rust rings from the cornea of the eye.

(b) Classification. Class I (general controls). When intended only for rust ring removal, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to §886.9.

[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2321, Jan. 14, 2000]