Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4670](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4670) → MUS — Fluidic, Phacoemulsification/Phacofragmentation

# MUS · Fluidic, Phacoemulsification/Phacofragmentation

_Ophthalmic · 21 CFR 886.4670 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MUS

## Overview

- **Product Code:** MUS
- **Device Name:** Fluidic, Phacoemulsification/Phacofragmentation
- **Regulation:** [21 CFR 886.4670](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4670)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## 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.

## Classification Rationale

Class II.

## Recent Cleared Devices (1 of 1)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K980292](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MUS/K980292.md) | CATARACT LIQUEFRACTURE DEVICE | Alcon Laboratories | May 19, 1998 | SESE |

## Top Applicants

- Alcon Laboratories — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MUS](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MUS)

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