| Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling. |
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| Device | MEL 80 EXCIMER LASER SYSTEM |
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| Generic Name | Excimer laser system |
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| Applicant | Carl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568 |
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| PMA Number | P060004 |
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| Date Received | 02/14/2006 |
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| Decision Date | 08/11/2006 |
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| Product Code |
LZS |
| Docket Number | 06M-0342 |
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| Notice Date | 08/25/2006 |
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| Advisory Committee |
Ophthalmic |
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| Expedited Review Granted? | No |
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| Combination Product | No |
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Approval Order Statement
APPROVAL FOR THE MEL 80 EXCIMER LASER SYSTEM. THE DEVICE USES AN OPTICAL ZONE OF 6.0 TO 7.0 MM IN DIAMETER AND A TRANSITION ZONE OF 1.7 TO 1.9 MM FOR TOTAL ABLATION DIAMETER OF 7.7 TO 8.9 MM, AND IS INDICATED FOR PRIMARY LASER ASSISTED IN SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR: 1) THE REDUCTION OR ELIMINATION OF MYOPIA OF LESS THAN OR EQUAL TO -7.0 D, WITH OR WITHOUT REFRACTIVE ASTIGMATISM OF LESS THAN OR EQUAL TO -3.0 D, WITH A MAXIMUM MRSE OF -7.00 D; 2) IN PATIENTS WHO ARE 21 YEARS OF AGE OR OLDER; 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 |
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| Summary | Summary of Safety and Effectiveness |
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| Labeling | Labeling
Labeling Part 2 |
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| Supplements: |
S001 S002 S004 S005 S007 |
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