21 CFR § 886.4670 - Phacofragmentation system.

---
identifier: "/us/cfr/t21/s886.4670"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.4670 - Phacofragmentation system."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.4670"
section_name: "Phacofragmentation system."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---


# 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.