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. |
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Device | SVS APEX EXCIMER LASER SYSTEM |
Generic Name | Excimer laser system |
Applicant | Alcon Laboratories, Inc. 2501 DISCOVERY DRIVE,SUITE 500 ORLANDO, FL 32826-3714 |
PMA Number | P930034 |
Date Received | 10/12/1993 |
Decision Date | 10/20/1995 |
Withdrawal Date
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05/18/2010 |
Product Code |
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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