CFR - Code of Federal Regulations Title 21

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For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

[Code of Federal Regulations]

[Title 21, Volume 8]

[CITE: 21CFR886.4070]

TITLE 21--FOOD AND DRUGS

CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES

SUBCHAPTER H - MEDICAL DEVICES

PART 886 -- OPHTHALMIC DEVICES

Subpart E - Surgical Devices

Sec. 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). 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.

[55 FR 48443, Nov. 20, 1990; 55 FR 51799, Dec. 17, 1990, as amended at 65 FR 2321, Jan. 14, 2000; 84 FR 71817, Dec. 30, 2019]