21 CFR § 886.4070 Ophthalmic Devices

§ 886.4070 Powered corneal burr.

Current through Sep 8, 2026 · Read all of Part 886

(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]

← § 886.3920 Aqueous shunt.§ 886.4100 Radiofrequency electrosurgical cautery apparatus. →