Code of Federal Regulations · Section
§ 886.4670 — Phacofragmentation System
21 C.F.R. § 886.4670
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(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.
Authorizing Statute
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Adulterated drugs and devices21 U.S.C. § 351