# LZS · Excimer Laser System

_ ·  · Class 3_

**Canonical URL:** https://fda-staging.innolitics.com/productcode/LZS

## Overview

- **Product Code:** LZS
- **Device Name:** Excimer Laser System
- **Regulation:** 21 CFR N/A
- **Device Class:** 3
- **Review Panel:** [](/submissions/)

## Recent Cleared Devices (20 of 55)

Showing 20 most recent of 55 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [P020050S043](/device/P020050S043.md) | WaveLight EX500 Laser | Alcon Laboratories, Inc. | Mar 5, 2025 | APPR |
| [P060004S006](/device/P060004S006.md) | MEL90 | Carl Zeiss Meditec, Inc. | Dec 4, 2024 | APPR |
| [P990027S021](/device/P990027S021.md) | TECHNOLAS TENEO™ 317 (MODEL 2) Excimer Laser System | Technolas Perfect Vision GmbH | Nov 22, 2023 | APPR |
| [P930016S057](/device/P930016S057.md) | STAR S4 IR Excimer Laser System and iDESIGN Refractive Studio | Amo Manufacturing USA, LLC | Sep 9, 2019 | APPR |
| [P930016S048](/device/P930016S048.md) | STAR S4 IR Excimer Laser System and iDesign Advanced WaveScan Studio System | Amo Manufacturing USA, LLC | Jun 30, 2017 | APPR |
| [P020050S023](/device/P020050S023.md) | WAVELIGHT EX500 EXCIMER LASER SYSTEM, ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM | Alcon Laboratories, Inc. | Nov 21, 2016 | APPR |
| [P930016S045](/device/P930016S045.md) | IDESIGN ADVANCED WAVESCAN STUDIO, STAR EXCIMER LASER SYSTEM | Amo Manufacturing USA, LLC | Nov 14, 2016 | APPR |
| [P930016S044](/device/P930016S044.md) | STAR S4 IR EXCIMER LASER SYSTEM WITH IDESIGN WAVESCAN STUDIO SYSTEM | Amo Manufacturing USA, LLC | May 6, 2015 | APPR |
| [P970053S011](/device/P970053S011.md) | NIDEK 2000 EC-5000 EXCIMER LASER SYSTEM | Nidek Co., Ltd. | Sep 30, 2013 | APPR |
| [P020050S012](/device/P020050S012.md) | ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM | Alcon Laboratories, Inc. | Sep 27, 2013 | APPR |
| [P060004S001](/device/P060004S001.md) | MEDITEC MEL 80 EXCIMER LASER SYSTEM | Carl Zeiss Meditec, Inc. | Mar 28, 2011 | APPR |
| [P930016S025](/device/P930016S025.md) | STAR S4 IR EXCIMER LASER SYSTEM & WAVESCAN SYSTEM | Amo Manufacturing USA, LLC | Jul 11, 2007 | APPR |
| [P970053S009](/device/P970053S009.md) | NIDEK EC-5000 EXCIMER LASER SYSTEM | Nidek Co., Ltd. | Oct 11, 2006 | APPR |
| [P060004](/device/P060004.md) | MEL 80 EXCIMER LASER SYSTEM | Carl Zeiss Meditec, Inc. | Aug 11, 2006 | APPR |
| [P020050S004](/device/P020050S004.md) | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM | Alcon Laboratories, Inc. | Jul 26, 2006 | APPR |
| [P970043S022](/device/P970043S022.md) | LADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM | Alcon Laboratories | May 2, 2006 | APPR |
| [P970043S020](/device/P970043S020.md) | LADARVISION 4000 EXCIMER LASER SYSTEM | Alcon Laboratories | May 1, 2006 | APPR |
| [P030008S004](/device/P030008S004.md) | WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM | Alcon Laboratories, Inc. | Apr 19, 2006 | APPR |
| [P930016S021](/device/P930016S021.md) | STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM | Amo Manufacturing USA, LLC | Aug 30, 2005 | APPR |
| [P930016S020](/device/P930016S020.md) | STAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) | Amo Manufacturing USA, LLC | Mar 17, 2005 | APPR |

## Top Applicants

- Amo Manufacturing USA, LLC — 18 clearances
- Alcon Laboratories, Inc. — 11 clearances
- Alcon Laboratories — 7 clearances
- Nidek Co., Ltd. — 5 clearances
- Technolas Perfect Vision GmbH — 5 clearances

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**Source:** [https://fda-staging.innolitics.com/productcode/LZS](https://fda-staging.innolitics.com/productcode/LZS)

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