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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.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
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