ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
FDA 510(k) clearance K223566 · decided 2023-04-14
Clearance details
- K-number
- K223566
- Device name
- ELITA™ Femtosecond Laser System, ELITA™ Patient Interface
- Applicant
- Johnson & Johnson Surgical Vision, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-11-29
- Decision date
- 2023-04-14
- Days to decision
- 136 days
- Clearance type
- Traditional
- Product code
- OOE
- Device class
- 2
- Regulation number
- 886.4390
- Medical specialty
- Ophthalmic
- Advisory committee
- Ophthalmic
- Location
- Irvine, CA, US
- Third-party review
- No
- Expedited review
- No
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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 |
| 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 |
| Catalys Precision Laser System (K182083) | Amo Manufacturing USA, LLC | 2018-11-09 |
| 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.