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Device | MEDITEC MEL 80 EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | Carl Zeiss Meditec, Inc. 5160 Hacienda Drive Dublin, CA 94568 |
PMA Number | P060004 |
Supplement Number | S001 |
Date Received | 12/28/2007 |
Decision Date | 03/28/2011 |
Product Code |
LZS |
Docket Number | 11M-0256 |
Notice Date | 04/25/2011 |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT00762281
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Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM. THIS DEVICE USES AN OPTICAL ZONE OF 6.0 TO 6.5 MM IN DIAMETER AND A TRANSITION ZONE OF 2.0 TO 4.0 MM FOR A TOTAL ABLATION DIAMETER OF 10.0 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF NATURALLY-OCCURRING HYPEROPIA OF LESS THAN OR EQUAL TO +5.0 D WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF > +0.5 AND <= +3.0D, WITH A MAXIMUM MRSE OF +5.0D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; AND 3) WITH DOCUMENTATION OF STABLE MANIFEST REFRACTION OVER THE PAST YEAR AS DEMONSTRATED BY CHANGE IN SPHERE AND CYLINDER OF <= 0.5D. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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