VISX STAR S2 EXCIMER LASER SYSTEM
FDA premarket approval P930016/S006 · decided 1998-03-20
Approval details
- PMA number
- P930016
- Supplement
- S006
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISX STAR S2 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 1998-02-26
- Decision date
- 1998-03-20
- Days to decision
- 22 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- Approval for for 1)laser removal of the epithelium; 2)visibility upgrade; 3)swivel mounted vacuum nozzle; 4)integrated hardware module with all unapproved indications "locked out"; 5)variable Hertz rate from 1.5 to 10 Hertz; 6)smoothing; 7)installation of software Version 2.2 with all unapproved indications "locked out"; and, 8)revised Operator's Manual. The device as modified will be marketed under the trade name VISX START S2 Excimer Laser System and is indicated for myopic and astigmatic PRK
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| Catalys™ Precision Laser System (K223838) | Amo Manufacturing USA, LLC | 2023-04-12 |
| CATALYS Precision Laser system (K220516) | Amo Manufacturing USA, LLC | 2022-05-17 |
| CATALYS Precision Laser System (K210701) | Amo Manufacturing USA, LLC | 2021-04-07 |
| Catalys Precision Laser System (K182083) | Amo Manufacturing USA, LLC | 2018-11-09 |
| Catalys Precision Laser System (K172002) | Amo Manufacturing USA, LLC | 2017-08-25 |
| IFS ADVANCED FEMTOSECOND LASER SYSTEM (K141852) | Amo Manufacturing USA, LLC | 2015-01-06 |