WAVELIGHT EX500 LASER SYSTEM
FDA premarket approval P030008/S016 · decided 2015-01-20
Approval details
- PMA number
- P030008
- Supplement
- S016
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVELIGHT EX500 LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2014-10-23
- Decision date
- 2015-01-20
- Days to decision
- 89 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM.
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