OOE — Ophthalmic Femtosecond Laser Class II
FDA product code OOE covers "Ophthalmic Femtosecond Laser", a Class II medical device regulated under 21 CFR 886.4390. Submissions are reviewed by the Ophthalmic panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- OOE
- Device Class
- Class II
- Regulation Number
- 886.4390
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252682 | alcon laboratories | LenSx Laser System (8065000944) | September 24, 2025 |
| K243896 | alcon laboratories | LenSx Laser System (8065998162) | April 28, 2025 |
| K223566 | johnson and johnson surgical vision | ELITA Femtosecond Laser System, ELITA Patient Interface | April 14, 2023 |
| K223838 | amo manufacturing usa | Catalys Precision Laser System | April 12, 2023 |
| K220259 | lensar | ALLY Adaptive Cataract Treatment System | June 9, 2022 |
| K220516 | amo manufacturing usa | CATALYS Precision Laser system | May 17, 2022 |
| K213559 | sie ag,surgical instrument engineering | FEMTO LDV Z8 Femtosecond Surgical Laser | April 21, 2022 |
| K210701 | amo manufacturing usa | CATALYS Precision Laser System | April 7, 2021 |
| K200724 | technolas perfect vision | VICTUS Femtosecond Laser Platform | September 1, 2020 |
| K200056 | amo manufacturng usa | Catalys Precision Laser System | May 18, 2020 |
| K182795 | lensar | LENSAR Laser System - fs 3D (LLS-fs 3D) | December 21, 2018 |
| K182083 | amo manufacturing usa | Catalys Precision Laser System | November 9, 2018 |
| K181430 | lensar | LENSAR Laser System - fs 3D (LLS-fs 3D) | August 9, 2018 |
| K173660 | alcon laboratories | LenSx Laser System | March 27, 2018 |
| K173346 | lensar | LENSAR Laser System - fs 3D (LLS-fs 3D) | March 2, 2018 |
| K171014 | technolas perfect vision | VICTUS Femtosecond Laser Platform | October 19, 2017 |
| K172002 | amo manufacturing usa | Catalys Precision Laser System | August 25, 2017 |
| K171337 | lensar | LENSAR Laser System fs 3D (LLS-fs 3D) | August 10, 2017 |
| K170322 | abbott medical optics | Catalys Precision Laser System | May 19, 2017 |
| K170576 | lensar | LENSAR Laser System - fs 3D (LLS-fs 3D) | May 5, 2017 |