VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
FDA premarket approval P910062/S001 · decided 2000-04-20
Approval details
- PMA number
- P910062
- Supplement
- S001
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- VISX STAR S3 EXCIMER LASER SYSTEM (WITH EYE TRACKER)
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2000-04-12
- Decision date
- 2000-04-20
- Days to decision
- 8 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- The device, as modified, will be marketed under the trade name VISX STAR S3 Excimer Laser System (with Eye Tracker) and is indicated for phototherapeutic keratectomy (PTK), myopic, astigmatic, and hyperopic (sphere only) photorefractive keratectomy (PRK) and myopic and astigmatic laser assisted in-situ keratomileusis (LASIK).
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510(k) clearances by this applicant
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|---|---|---|
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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 |