SVS APEX PLUS EXCIMER LASER WORKSTATION
FDA premarket approval P910067/S003 · decided 1998-06-04
Approval details
- PMA number
- P910067
- Supplement
- S003
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- SVS APEX PLUS EXCIMER LASER WORKSTATION
- Generic name
- Excimer laser system
- Applicant
- Alcon Research, Ltd. Dba Alcon Laboratories, Inc.
- Date received
- 1998-05-21
- Decision date
- 1998-06-04
- Days to decision
- 14 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- Approval for an external chiller option for the SVS Apex Plus Excimer Laser System.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| WAVELIGHT FS200 LASER SYSTEM (K141476) | Alcon Research, Ltd. Dba Alcon Laboratories, Inc. | 2014-09-30 |