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§ 886.4670 Phacofragmentation system.

21 CFR 886.4670

Citation21 CFR 886.4670
CorpusDaily eCFR
Displayed edition2026-05-13
Last updated2026-05-13

§ 886.4670 Phacofragmentation system.

(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.