Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150) → MLZ — Vitrectomy, Instrument Cutter

# MLZ · Vitrectomy, Instrument Cutter

_Ophthalmic · 21 CFR 886.4150 · Class 2_

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

## Overview

- **Product Code:** MLZ
- **Device Name:** Vitrectomy, Instrument Cutter
- **Regulation:** [21 CFR 886.4150](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4150)
- **Device Class:** 2
- **Review Panel:** [Ophthalmic](/submissions/OP)
- **3rd-party reviewable:** yes

## Identification

A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.

## Classification Rationale

Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Special Controls

*Classification.* Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

## Recent Cleared Devices (4 of 4)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K220030](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MLZ/K220030.md) | Vista Ophthalmics Vitrectomy Probe | Vista Ophthalmics, LLC | May 4, 2022 | SESE |
| [K170520](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MLZ/K170520.md) | HyperVit Vitrectomy Probe, 23 GA, HyperVit Vitrectomy Probe, 25+, HyperVit Vitrectomy Probe, 27+ | Alcon Research, Ltd. | Mar 22, 2017 | SESE |
| [K093305](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MLZ/K093305.md) | ENHANCED ULTRA VIT PROBE | Alcon Research, Ltd. | Apr 2, 2010 | SESE |
| [K081681](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/MLZ/K081681.md) | VITRECTOMY CUTTER AND ACCESSORIES | Advanced Medical Optics, Inc. | Oct 8, 2008 | SESE |

## Top Applicants

- Alcon Research, Ltd. — 2 clearances
- Vista Ophthalmics, LLC — 1 clearance
- Advanced Medical Optics, Inc. — 1 clearance

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

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