Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
|
Device | LADARVISION 4000 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | ALCON LABORATORIES 6201 S FREEWAY FT WORTH, TX 76134 |
PMA Number | P970043 |
Supplement Number | S010 |
Date Received | 03/18/2002 |
Decision Date | 10/18/2002 |
Withdrawal Date
|
05/15/2012 |
Product Code |
LZS |
Docket Number | 02M-0487 |
Notice Date | 11/18/2002 |
Advisory Committee |
Ophthalmic |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE LADARVISION 4000 EXCIMER LASER SYSTEM. THIS DEVICE USES A 6.5 MM OPTICAL ZONE, A 9.0 MM TREATMENT ZONE, IS LOCKED-OUT FOR TREATMENTS ABOVE -7.0 DIOPTERS (D) AS MEASURED BY MANIFEST REFRACTION, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA UP TO -7.00 D WITH LESS THAN -0.50 D OF ASTIGMATISM AT THE SPECTACLE PLANE; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTED STABILITY OF REFRACTION FOR THE PRIOR 12 MONTHS, AS DEMONSTRATED BY A CHANGE OF LESS THAN OR EQUAL TO 0.50 D. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
|
|