Catalys Precision Laser System
FDA 510(k) clearance K182083 · decided 2018-11-09
Clearance details
- K-number
- K182083
- Device name
- Catalys Precision Laser System
- Applicant
- Amo Manufacturing USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2018-08-02
- Decision date
- 2018-11-09
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- OOE
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Milpitas, CA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Amo Manufacturing USA
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| LenSx Laser System (8065000944) (K252682) | Alcon Laboratories, Inc. | 2025-09-24 |
| LenSx Laser System (8065998162) (K243896) | Alcon Laboratories, Inc. | 2025-04-28 |
| ELITA™ Femtosecond Laser System, ELITA™ Patient Interface (K223566) | Johnson & Johnson Surgical Vision, Inc. | 2023-04-14 |
| Catalys™ Precision Laser System (K223838) | Amo Manufacturing USA, LLC | 2023-04-12 |
| ALLY Adaptive Cataract Treatment System (K220259) | Lensar, Inc. | 2022-06-09 |
| CATALYS Precision Laser system (K220516) | Amo Manufacturing USA, LLC | 2022-05-17 |
| FEMTO LDV Z8 Femtosecond Surgical Laser (K213559) | Sie Ag,Surgical Instrument Engineering | 2022-04-21 |
| CATALYS Precision Laser System (K210701) | Amo Manufacturing USA, LLC | 2021-04-07 |
| VICTUS Femtosecond Laser Platform (K200724) | Technolas Perfect Vision GmbH | 2020-09-01 |
| Catalys Precision Laser System (K200056) | Amo Manufacturng USA, LLC | 2020-05-18 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K182795) | Lensar, Inc. | 2018-12-21 |
| LENSAR Laser System - fs 3D (LLS-fs 3D) (K181430) | Lensar, Inc. | 2018-08-09 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| iDESIGN Refractive Studio, STAR S4 IR Excimer Laser System (P930016/S067) | Amo Manufacturing USA, LLC | 2024-08-09 |
| STAR S4 IR Excimer Laser (P930016/S065) | Amo Manufacturing USA, LLC | 2024-07-01 |
| iDesign Refractive Studio (P930016/S066) | Amo Manufacturing USA, LLC | 2024-03-22 |
| iDesign Refractive Studio (iDesign/G301) (P930016/S064) | Amo Manufacturing USA, LLC | 2024-03-21 |
| iDesign Refractive Studio (P930016/S063) | Amo Manufacturing USA, LLC | 2023-10-16 |
| iDesign Advanced WaveScan Studio, STAR Excimer Laser System (P930016/S062) | Amo Manufacturing USA, LLC | 2021-02-26 |
| iDESIGN Refractive Studio (P930016/S061) | Amo Manufacturing USA, LLC | 2020-02-14 |
| iDESIGN Refractive Studio (P930016/S060) | Amo Manufacturing USA, LLC | 2020-01-28 |