WAVELIGHT EX500 EXCIMER LASER SYSTEM
FDA premarket approval P020050/S010 · decided 2013-11-25
Approval details
- PMA number
- P020050
- Supplement
- S010
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- WAVELIGHT EX500 EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2012-11-05
- Decision date
- 2013-11-25
- Days to decision
- 385 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR A REGISTRATION FEATURE THAT ENABLES PUPIL CENTER SHIFT COMPENSATION AND CYCLOTORSION ADJUSTMENT BASED ON COMPARISON OF DIAGNOSTIC AND TREATMENT IMAGES.
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