Catalys Precision Laser System
FDA 510(k) K170322 · Abbott Medical Optics, Inc.
510(k) numberK170322
Submission
- Device name
- Catalys Precision Laser System
- Applicant
- Abbott Medical Optics, Inc.
Milpitas, CA, US - Received
- February 1, 2017
- Decision date
- May 19, 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 |
|---|---|---|
| K160236 | Dual Pump PackHQC · Abbreviated | 04/27/2016SE |
| K151636 | AMO WHITESTAR Signature Pro Phacoemulsification System, WHITESTAR Signature Pro Advance…HQC · Traditional | 10/19/2015SE |
| K151783 | COMPACT INTUITIV Multiple-Use PackHQC · Abbreviated | 09/02/2015SE |
| K143434 | One Series ULTRA Cartridge, The UNFOLDER Platinum 1 SeriesMSS · Abbreviated | 05/06/2015SE |
| K133115 | Compact Intuitiv; System, Wireless Remote Control, Four-Button Foot Pedal, Single-Use…HQC · Abbreviated | 02/27/2014SE |
| K121721 | Laminar Flow Phaco Tips and Irrigation Sleeve (21G, Reusable)HQC · Traditional | 10/15/2012SE |
| K113151 | Ifs Laser SystemGEX · Traditional | 03/08/2012SE |
| K111446 | Sovereign Compact Phacoemulsification SystemHQC · Traditional | 12/21/2011SE |
| K111882 | Laminar Flow Phaco TipsHQC · Abbreviated | 11/07/2011SE |
| K111697 | Amo Whitestar Signature Phacoemulsification SystemHQC · Abbreviated | 09/27/2011SE |
Questions and answers
When was Catalys Precision Laser System cleared by the FDA?
Catalys Precision Laser System (K170322) received a 510(k) decision of Substantially Equivalent on May 19, 2017, 107 days after the submission was received.
What is the product code of K170322?
The FDA product code is OOE – Ophthalmic Femtosecond Laser, a Class II (moderate risk) device regulated under 21 CFR 886.4390.