21 CFR § 886.4670 Ophthalmic Devices

§ 886.4670 Phacofragmentation system.

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

(a) Identification. A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

(b) Classification. Class II.

← § 886.4610 Ocular pressure applicator.§ 886.4690 Ophthalmic photocoagulator. →