LenSx Laser System
FDA 510(k) K163551 · Alcon Laboratories, Inc.
510(k) numberK163551
Submission
- Device name
- LenSx Laser System
- Applicant
- Alcon Laboratories, Inc.
Lake Forest, CA, US - Received
- December 19, 2016
- Decision date
- February 3, 2017
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OOE – Ophthalmic Femtosecond Laser
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 886.4390
- Specialty
- Ophthalmic
Precise cutting or ablation of ocular tissue, indicated for the anterior capsulotomy during cataract surgery.
Other 510(k)s with product code OOE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K252682 | LenSx Laser System (8065000944)OOE · Special | Alcon Laboratories, Inc. | 09/24/2025SE |
| K243896 | LenSx Laser System (8065998162)OOE · Traditional | Alcon Laboratories, Inc. | 04/28/2025SE |
| K223566 | ELITA Femtosecond Laser System, ELITA Patient InterfaceOOE · Traditional | Johnson & Johnson Surgical Vision, Inc. | 04/14/2023SE |
| K223838 | Catalys Precision Laser SystemOOE · Traditional | Amo Manufacturing USA, LLC | 04/12/2023SE |
| K220259 | ALLY Adaptive Cataract Treatment SystemOOE · Traditional | Lensar, Inc. | 06/09/2022SE |
| K220516 | CATALYS Precision Laser systemOOE · Traditional | Amo Manufacturing USA, LLC | 05/17/2022SE |
| K213559 | FEMTO LDV Z8 Femtosecond Surgical LaserOOE · Traditional | Sie Ag,Surgical Instrument Engineering | 04/21/2022SE |
| K210701 | CATALYS Precision Laser SystemOOE · Special | Amo Manufacturing USA, LLC | 04/07/2021SE |
| K200724 | VICTUS Femtosecond Laser PlatformOOE · Traditional | Technolas Perfect Vision GmbH | 09/01/2020SE |
| K200056 | Catalys Precision Laser SystemOOE · Traditional | Amo Manufacturng USA, LLC | 05/18/2020SE |
More from Amo Manufacturng USA, LLC
| 510(k) | Device | Decision |
|---|---|---|
| K254052 | DAILIES TOTAL1®; DAILIES TOTAL1® MultifocalLPL · Traditional | 02/13/2026SE |
| K252682 | LenSx Laser System (8065000944)OOE · Special | 09/24/2025SE |
| K243896 | LenSx Laser System (8065998162)OOE · Traditional | 04/28/2025SE |
| K243909 | Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism…LPL · Special | 01/13/2025SE |
| K242184 | Alcon 27GA Chandelier (8065000252); Alcon 27+ DS Wide Angle Endoilluminator…MPA · Traditional | 12/04/2024SE |
| K233876 | Unity VCS (8065000296); Unity CS (8065000297)HQC · Traditional | 06/21/2024SE |
| K233902 | Centurion Vision System (Active Sentry) (8065753057)HQC · Special | 01/10/2024SE |
| K233856 | Precision1; Precision1 for Astigmatism; TOTAL30; TOTAL30 for Astigmatism; TOTAL30…LPL · Special | 12/29/2023SE |
| K232921 | DAILIES TOTAL1®; DAILIES TOTAL1® Toric; DAILIES TOTAL1® Multifocal; DAILIES TOTAL1®…LPL · Traditional | 11/16/2023SE |
| K230785 | Precision1, Precision1 for AstigmatismLPL · Special | 04/20/2023SE |
Questions and answers
When was LenSx Laser System cleared by the FDA?
LenSx Laser System (K163551) received a 510(k) decision of Substantially Equivalent on February 3, 2017, 46 days after the submission was received.
What is the product code of K163551?
The FDA product code is OOE – Ophthalmic Femtosecond Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.