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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceSVS APEX PLUS EXCIMER LASER WORKSTATION
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
2501 discovery drive,suite 500
orlando, FL 32826-3714
PMA NumberP930034
Supplement NumberS013
Date Received02/11/1999
Decision Date10/21/1999
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1591
Notice Date 11/03/2000
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
APPROVAL FOR THE SVS APEX PLUS EXCIMER LASER WORKSTATION AND EMPHASIS(R) "M" DISCS (M00-M09) THESE DEVICES ARE INDICATED TO PERFORM LASIK: 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA RANGING FROM 0.0 TO -14.0 DIOPTERS (D) WITH OR WITHOUT ASTIGMATISM RANGING FROM -0.5D TO -5.0D; 2) IN PATIENTS 18 YEARS OF AGE OR OLDER; AND 3) IN PATIENTS WITH DOCUMENTATION OF A STABLE MANIFEST REFRACTION (+0.5D) OVER THE PAST YEAR.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
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