Catalys Precision Laser System
FDA 510(k) K182083 · Amo Manufacturing USA, LLC
510(k) numberK182083
Submission
- Device name
- Catalys Precision Laser System
- Applicant
- Amo Manufacturing USA, LLC
Milpitas, CA, US - Received
- August 2, 2018
- Decision date
- November 9, 2018
- 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 |
|---|---|---|
| K223838 | Catalys Precision Laser SystemOOE · Traditional | 04/12/2023SE |
| K220516 | CATALYS Precision Laser systemOOE · Traditional | 05/17/2022SE |
| K210701 | CATALYS Precision Laser SystemOOE · Special | 04/07/2021SE |
| K172002 | Catalys Precision Laser SystemOOE · Traditional | 08/25/2017SE |
| K141852 | Ifs Advanced Femtosecond Laser SystemGEX · Traditional | 01/06/2015SE |
Questions and answers
When was Catalys Precision Laser System cleared by the FDA?
Catalys Precision Laser System (K182083) received a 510(k) decision of Substantially Equivalent on November 9, 2018, 99 days after the submission was received.
What is the product code of K182083?
The FDA product code is OOE – Ophthalmic Femtosecond Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.