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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.
 
DeviceSVS APEX EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
Alcon Laboratories, Inc.
2501 discovery drive,suite 500
orlando, FL 32826-3714
PMA NumberP930034
Date Received10/12/1993
Decision Date10/20/1995
Withdrawal Date 05/18/2010
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 96M-0274
Notice Date 08/15/1996
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
INDICATED FOR A 6.0 MM ABLATION ZONE, MYOPIC PHOTOREFRACTIVE KERATECTOMY (PRK) IN PATIENTS WHO MEET ALL OF THE FOLLOWING CRITERIA:1)1.5 TO 7.0 DIOPTERS OF MYOPIA WITH ASTIGMATISM OF <- 1.5 DIOPTERS; 2)REFRACTION IS WITHIN +- 1.0 DIOPTER FOR ONE YEAR PRIOR TOT HE LASER TREATMENT; AND 3) 21 YEARS OF AGE OR OLDER
Supplements: S001 S002 S003 S006 S007 S008 S009 S011 S012 
S013 S015 
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