Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart E - Surgical Devices / § 886.4070 Powered corneal burr.
§ 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.