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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceMEL 80 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantCarl Zeiss Meditec, Inc.
5160 Hacienda Drive
Dublin, CA 94568
PMA NumberP060004
Date Received02/14/2006
Decision Date08/11/2006
Product Code LZS 
Docket Number 06M-0342
Notice Date 08/25/2006
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Supplements: S004 S005 S007  S001 S002 
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