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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.
 
Trade NameLADARVISION EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nametracker assisted excimer laser system
ApplicantALCON LABORATORIES
PMA NumberP970043
Date Received09/05/1997
Decision Date11/02/1998
Withdrawal Date 05/15/2012
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1592
Notice Date 02/05/2001
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
Indicated for use in photorefractive keratectomy (prk) treatment for the reduction or elimination of mild to moderate myopia in patients with the following three characteristics: 1) between -1. 00d to -10. 00d of sphere and less than or equal to -4. 00d of astigmatism at the spectacle plane, the combination of which must result in an attempted correction between -0. 50d and -10. 00d spherical equivalent (se) at the spectacle plane where sphere or cylinder is at least 1. 00d; 2) who are 21 years of age or older; and 3) with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0. 50d for corrections up to -7. 00d se, and less than or equal to -1. 00d for corrections greater than -7. 00 d se.
Approval Order Approval Order
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S013 S014 S015 S016 S017 S019 S020 
S021 S022 S023 S025 S026 
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