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Device | BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION |
Generic Name | Excimer laser system |
Applicant | TECHNOLAS PERFECT VISION GMBH MESSERSCHMITTSTR 1 + 3 MUNCHEN 80992 |
PMA Number | P990027 |
Supplement Number | S006 |
Date Received | 07/18/2002 |
Decision Date | 10/10/2003 |
Product Code |
LZS |
Docket Number | 03M-0533 |
Notice Date | 11/24/2003 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION. THE DEVICE USES AN OPTICAL ZONE SIZE BETWEEN 6.0 MM AND 7.0 MM WITH A CONSTANT BLEND ZONE OF .875 MM, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO -3.00 D AND MRSE <=7.50 D AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO +=0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEAR PRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION; AND 3) IN PATIENTS 21 YEARS OF AGE OR OLDER. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |