|
Device | TECHNOLAS EXCIMER LASER SYSTEM (217A AND 217Z) |
Generic Name | excimer laser system |
Applicant |
TECHNOLAS PERFECT VISION GMBH |
messerschmittstr 1 + 3 |
munchen 80992 |
|
PMA Number | P990027 |
Date Received | 05/28/1999 |
Decision Date | 02/23/2000 |
Product Code |
LZS
|
Docket Number | 00M-1597 |
Notice Date | 11/03/2000 |
Advisory Committee |
Ophthalmic |
Expedited Review Granted? | No |
Combination Product |
No
|
Approval Order Statement
APPROVAL FOR THE TECHNOLAS(R) 217A EXCIMER LASER SYSTEM. THE DEVICES IS INDICATED TO PERFORM LASER IN-SITU KERATOMILEUSIS (LASIK): 1) IN TREATMENTS FOR THE REDUCTION OR ELIMINATINO OF MYOPIA (NEARSIGHTEDNESS) FROM -1.00 TO -7.00 DIOPTERS D WITH LESS THAN -3.00 D ASTIGMATISM; 2) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS AS DEMONSTRATED BY A CHANGE IN MANIFEST REFRACTION OF LESS THAN OR EQUAL TO 0.5 D (IN BOTH CYLINDER AND SPHERE COMPONENTS); AND, 3) IN PATIENTS 21 YEARS OF AGE OR OLDER. |
Approval Order |
Approval Order
|
Summary |
Summary of Safety and Effectiveness |
Labeling |
Labeling
|
Supplements: |
S019 S020 S007 S001 S012 S005 S004 S016 S009 S011 S013 S010 S003 S006 S002 S015 S018 S017 |