PMA P020050S012
- Device
- ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S012
- Product code
- LZS
- Decision date
- 2013-09-27
- Classification
- Excimer Laser System
- Generic name
- Excimer laser system
- Approval order 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 WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.¿
- Summary
- <a href="http://www.accessdata.fda.gov/cdrh_docs/pdf2/P020050S012B.pdf" target="_new">Summary of Safety and Effectiveness</a>
Current openFDA PMA Record#
- Device
- ALLEGRETTO WAVE EYE-Q EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories, Inc.
- PMA number
- P020050
- Supplement
- S012
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2013-09-27
- Decision code
- APPR
- Date received
- 2013-04-01
- Supplement type
- Panel Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order 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 WITH ASTIGMATISM, WITH UP TO -8.00 D OF SPHERICAL COMPONENT AND UP TO -3.00D OF ASTIGMATIC COMPONENT AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION DEFINED AS 0.50D OR LESS OF PREOPERATIVE SPHERICAL EQUIVALENT SHIFT OVER ONE YEAR PRIOR TO SURGERY.¿