Browse hierarchy: [Ophthalmic (OP)](/submissions/OP) → [Subpart E — Surgical Devices](/submissions/OP/subpart-e%E2%80%94surgical-devices) → [21 CFR 886.4390](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4390) → OOE — Ophthalmic Femtosecond Laser # OOE · Ophthalmic Femtosecond Laser _Ophthalmic · 21 CFR 886.4390 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE ## Overview - **Product Code:** OOE - **Device Name:** Ophthalmic Femtosecond Laser - **Regulation:** [21 CFR 886.4390](/submissions/OP/subpart-e%E2%80%94surgical-devices/886.4390) - **Device Class:** 2 - **Review Panel:** [Ophthalmic](/submissions/OP) ## 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](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K252682.md) | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | Sep 24, 2025 | SESE | | [K243896](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K243896.md) | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | Apr 28, 2025 | SESE | | [K223566](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K223566.md) | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Johnson & Johnson Surgical Vision, Inc. | Apr 14, 2023 | SESE | | [K223838](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K223838.md) | Catalys™ Precision Laser System | Amo Manufacturing USA, LLC | Apr 12, 2023 | SESE | | [K220259](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K220259.md) | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | Jun 9, 2022 | SESE | | [K220516](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K220516.md) | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | May 17, 2022 | SESE | | [K213559](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K213559.md) | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | Apr 21, 2022 | SESE | | [K210701](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K210701.md) | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | Apr 7, 2021 | SESE | | [K200724](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K200724.md) | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | Sep 1, 2020 | SESE | | [K200056](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K200056.md) | Catalys Precision Laser System | Amo Manufacturng USA, LLC | May 18, 2020 | SESE | | [K182795](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K182795.md) | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Dec 21, 2018 | SESE | | [K182083](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K182083.md) | Catalys Precision Laser System | Amo Manufacturing USA, LLC | Nov 9, 2018 | SESE | | [K181430](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K181430.md) | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Aug 9, 2018 | SESE | | [K173660](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K173660.md) | LenSx Laser System | Alcon Laboratories, Inc. | Mar 27, 2018 | SESE | | [K173346](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K173346.md) | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | Mar 2, 2018 | SESE | | [K171014](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K171014.md) | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | Oct 19, 2017 | SESE | | [K172002](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K172002.md) | Catalys Precision Laser System | Amo Manufacturing USA, LLC | Aug 25, 2017 | SESE | | [K171337](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K171337.md) | LENSAR Laser System – fs 3D (LLS-fs 3D) | Lensar, Inc. | Aug 10, 2017 | SESE | | [K170322](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K170322.md) | Catalys Precision Laser System | Abbott Medical Optics, Inc. | May 19, 2017 | SESE | | [K170576](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE/K170576.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/OOE) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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