ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
FDA premarket approval P020050/S012 · decided 2013-09-27
Approval details
- PMA number
- P020050
- Supplement
- S012
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2013-04-01
- Decision date
- 2013-09-27
- Days to decision
- 179 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Fort Worth, TX
- Statement
- APPROVAL FOR THE ALLEGRETTO WAVE® EYE-Q 400HZ EXCIMER LASER SYSTEM. THIS DEVICE IS INDICATED FOR THE FOLLOWING: THE WAVELIGHT ALLEGRETTO WAVE® EYE-Q EXCIMER LASER SYSTEM USED IN CONJUNCTION WITH THE WAVELIGHT ALLEGRO TOPOLYZER (TOPOGRAPHER) AND T-CAT TREATMENT PLANNING SOFTWARE IS INDICATED FOR PERFORMING TOPOGRAPHY-GUIDED LASER ASSISTED IN SITU KERATOMILEUSIS (TOPO-GUIDED (T-CAT) LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF UP TO -9.00 DIOPTERS (D) OF SPHERICAL EQUIVALENT MYOPIA OR MYOPIA WIT
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