STAR EXCIMER LASER SYSTEM
FDA premarket approval P930016/S046 · decided 2016-01-11
Approval details
- PMA number
- P930016
- Supplement
- S046
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAR EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2015-10-19
- Decision date
- 2016-01-11
- Days to decision
- 84 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR CHANGES TO THE FRONT PANEL ASSEMBLY OF THE STAR S4 IR SYSTEM WITH RELATED CHANGES AND MINOR UPDATES TO THE STAR S4 IR OPERATORS MANUAL.
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510(k) clearances by this applicant
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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 |