21 C.F.R. § 886.4670 Phacofragmentation system.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices
§ 886.4670 Phacofragmentation system.