VISX STAR S2/S3 EXCIMER LASER SYSTEM
FDA premarket approval P930016/S013 · decided 2001-03-19
Approval details
- PMA number
- P930016
- Supplement
- S013
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISX STAR S2/S3 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2001-02-05
- Decision date
- 2001-03-19
- Days to decision
- 42 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL TO ADD AN 8 MM BLEND ZONE THAT INCREASES THE OVERALL DIAMETER OF THE ABLATION ZONE FROM 6.5 TO 8.0 MM.
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510(k) clearances by this applicant
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| Catalys™ Precision Laser System (K223838) | Amo Manufacturing USA, LLC | 2023-04-12 |
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| 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 |