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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
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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