Product code OOE
- Device name
- Ophthalmic Femtosecond Laser
- Medical specialty
- Ophthalmic
- Device class
- 2
- Regulation number
- 886.4390
- Review panel
- OP
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Definition
- Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252682 | LenSx Laser System (8065000944) | Alcon Laboratories, Inc. | 2025-09-24 |
| K243896 | LenSx Laser System (8065998162) | Alcon Laboratories, Inc. | 2025-04-28 |
| K223566 | ELITA™ Femtosecond Laser System, ELITA™ Patient Interface | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| K223838 | Catalys™ Precision Laser System | Amo Manufacturing USA, LLC | 2023-04-12 |
| K220259 | ALLY Adaptive Cataract Treatment System | Lensar, Inc. | 2022-06-09 |
| K220516 | CATALYS Precision Laser system | Amo Manufacturing USA, LLC | 2022-05-17 |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2022-04-21 |
| K210701 | CATALYS Precision Laser System | Amo Manufacturing USA, LLC | 2021-04-07 |
| K200724 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2020-09-01 |
| K200056 | Catalys Precision Laser System | Amo Manufacturng USA, LLC | 2020-05-18 |
| K182795 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-12-21 |
| K182083 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2018-11-09 |
| K181430 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-08-09 |
| K173660 | LenSx Laser System | Alcon Laboratories, Inc. | 2018-03-27 |
| K173346 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2018-03-02 |
| K171014 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2017-10-19 |
| K172002 | Catalys Precision Laser System | Amo Manufacturing USA, LLC | 2017-08-25 |
| K171337 | LENSAR Laser System – fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-08-10 |
| K170322 | Catalys Precision Laser System | Abbott Medical Optics, Inc. | 2017-05-19 |
| K170576 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2017-05-05 |
| K163551 | LenSx Laser System | Alcon Laboratories, Inc. | 2017-02-03 |
| K161288 | LenSX Laser System | Alcon Laboratories, Inc. | 2016-11-16 |
| K161455 | Catalys Precision Laser System | Optimedica Corporation | 2016-09-20 |
| K150323 | FEMTO LDV Z8 Surgical Laser | Sie Ag,Surgical Instrument Engineering | 2015-10-23 |
| K152453 | LENSAR Laser System - fs 3D (LLS-fs 3D) | Lensar, Inc. | 2015-10-15 |
| K151161 | VICTUS Femtosecond Laser Platform | Technolas Perfect Vision GmbH | 2015-06-24 |
| K143010 | LENSAR Laser System - fs 3D | Lensar, Inc. | 2015-03-20 |
| K141379 | VICTUS FEMTOSECOND LASER PLATFORM | Technolas Perfect Vision GmbH | 2015-01-16 |
| K141476 | WAVELIGHT FS200 LASER SYSTEM | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014-09-30 |
| K141079 | OPTIMEDICA CATALYS PRECISION LASER SYSTEM | Optimedica Corporation | 2014-09-11 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00867744000181 | ALLY | LENSAR, Inc. | 2026-04-13 |
| 00867744000174 | LLS/ALLY | LENSAR, Inc. | 2026-04-13 |
| 00867744000167 | LLS/ALLY | LENSAR, Inc. | 2026-04-13 |
| 00850062486027 | LLS/ALLY | LENSAR, Inc. | 2026-04-13 |
| 00380650009449 | LenSx | Alcon Laboratories, Inc. | 2025-10-01 |
| 04050555002086 | Patient Interface 125 Kit | Technolas Perfect Vision GmbH | 2024-03-13 |
| 00867744000150 | ALLY | LENSAR, Inc. | 2023-08-18 |
| 10867744000157 | ALLY | LENSAR, LLC | 2023-08-18 |
| 05050474738553 | ELITA | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2023-08-11 |
| 05050474655706 | INTRALASE TECHNOLOGY PI | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2023-08-11 |
| 05050474655690 | INTRALASE TECHNOLOGY PI | JOHNSON & JOHNSON SURGICAL VISION, INC. | 2023-08-11 |
| 07640167750573 | FEMTO | SIE AG, Surgical Instrument Engineering | 2022-06-10 |
| 07640167751334 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2020-12-22 |
| 07640167751341 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2020-12-22 |
| 07640167751358 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2020-12-22 |
| 07640167751365 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2020-12-22 |
| 07640167751372 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2020-12-22 |
| 07640167751389 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2020-12-22 |
| 07640167750627 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750603 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750580 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750566 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750542 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750528 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 07640167750511 | Procedure Pack Z8 | SIE AG, Surgical Instrument Engineering | 2018-09-14 |
| 04050555004165 | VICTUS VERAFIT Patient Interface Kit | Technolas Perfect Vision GmbH | 2016-12-05 |
| 04050555000990 | Patient Interface 125 Kit | Technolas Perfect Vision GmbH | 2016-09-24 |
| 00867744000112 | LENSAR LLS-fs 3D | LENSAR, Inc. | 2016-09-24 |
| 00867744000105 | LENSAR LLS-fs 3D | LENSAR, Inc. | 2016-09-24 |
| 00380659908194 | WaveLight | Alcon Laboratories, Inc. | 2016-09-24 |