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21 CFR 886.4670

§ 886.4670 Phacofragmentation system.

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 886.4670, § 886.4670 Phacofragmentation system, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90998
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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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.