---
kind: "section"
citation: "21 C.F.R. § 886.4670"
title: "21"
number: "886.4670"
heading: "Phacofragmentation system."
url: "https://uscodex.org/cfr/21/886.4670"
---

# §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.

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.

### Source

Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.