GroundRules
21 CFR 886.4070: Powered corneal burr.
Where this section sits in the code
- 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
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON