OOE · Ophthalmic Femtosecond Laser
Ophthalmic · 21 CFR 886.4390 · Class 2
Overview
| Product Code | OOE |
|---|---|
| Device Name | Ophthalmic Femtosecond Laser |
| Regulation | 21 CFR 886.4390 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
An ophthalmic laser is an AC-powered device intended to coagulate or cut tissue of the eye, orbit, or surrounding skin by a laser beam.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 47)
Showing 20 most recent of 47 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | Sep 24, 2025 | SESE |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | Apr 28, 2025 | SESE |
| K223566 | ELITA Femtosecond Laser System, ELITA Patient Interface | Johnson & Johnson Surgical Vision, Inc. | Apr 14, 2023 | SESE |
| K223838 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | Apr 12, 2023 | SESE |
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | Jun 9, 2022 | SESE |
| K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | May 17, 2022 | SESE |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | Apr 21, 2022 | SESE |
| K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | Apr 7, 2021 | SESE |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | Sep 1, 2020 | SESE |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | May 18, 2020 | SESE |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Dec 21, 2018 | SESE |
| K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | Nov 9, 2018 | SESE |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Aug 9, 2018 | SESE |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | Mar 27, 2018 | SESE |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Mar 2, 2018 | SESE |
| K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | Oct 19, 2017 | SESE |
| K172002 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | Aug 25, 2017 | SESE |
| K171337 | LENSAR Laser System fs 3D (LLS-fs 3D) | Lensar, Inc. | Aug 10, 2017 | SESE |
| K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | May 19, 2017 | SESE |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | May 5, 2017 | SESE |
Top Applicants
- Lensar, Inc. — 13 clearances
- Technolas Perfect Vision GmbH — 9 clearances
- Alcon Laboratories, Inc. — 5 clearances
- Amo Manufacturing USA, LLC — 5 clearances
- Lensx Lasers, Inc. — 4 clearances
