21 C.F.R. § 886.4670

Phacofragmentation system.

Last amended: 2016Year: 2026Length: 33 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 886.4670 (2026)

(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.
21 C.F.R. § 886.4670: Phacofragmentation system. | Justis AI