CATALYS Precision Laser System
FDA 510(k) clearance K210701 · decided 2021-04-07
Clearance details
- K-number
- K210701
- Device name
- CATALYS Precision Laser System
- Applicant
- Amo Manufacturing USA, LLC
- Decision
- Substantially Equivalent
- Date received
- 2021-03-09
- Decision date
- 2021-04-07
- Days to decision
- 29 days
- Clearance type
- Special
- 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
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| FEMTO LDV Z8 Femtosecond Surgical Laser (K213559) | Sie Ag,Surgical Instrument Engineering | 2022-04-21 |
| VICTUS Femtosecond Laser Platform (K200724) | Technolas Perfect Vision GmbH | 2020-09-01 |
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| 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.
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 |