WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
FDA premarket approval P020050/S014 · decided 2013-10-18
Approval details
- PMA number
- P020050
- Supplement
- S014
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVELIGHT ALLEGRETTO WAVE EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2013-07-22
- Decision date
- 2013-10-18
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE WAVENET¿ PLANNING SOFTWARE (WPS), A STAND-ALONE USER INTERFACE SOFTWARE SYSTEM FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM. THE WPS ENABLES THE PHYSICIAN TO PLAN SURGICAL CASES REMOTELY IN ADVANCE OF THE PLANNED SURGICAL DATE.
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