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