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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceMEDITEC MEL 80 EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantCarl Zeiss Meditec, Inc.
5160 Hacienda Dr.
Dublin, CA 94568
PMA NumberP060004
Supplement NumberS001
Date Received12/28/2007
Decision Date03/28/2011
Product Code LZS 
Docket Number 11M-0256
Notice Date 04/25/2011
Advisory Committee Ophthalmic
Clinical TrialsNCT00762281
Supplement TypePanel Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
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