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) → MXO — Laser, System, Phacolysis

# MXO · Laser, System, Phacolysis

_Ophthalmic · 21 CFR 886.4670 · Class 2_

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

## Overview

- **Product Code:** MXO
- **Device Name:** Laser, System, Phacolysis
- **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 (0 of 0)

_No cleared devices on record._

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

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