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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.
 
DeviceLASERSCAN LSX EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
LASERSIGHT TECHNOLOGIES, INC.
6903 university blvd.,
winter park, FL 32792
PMA NumberP980008
Date Received03/19/1998
Decision Date11/12/1999
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1231
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the laserscan lsx excimer laser system. The device is indicated for myopic photorefractive keratectomy: for the reduction or elimination of myopia ranging from -1. 0 to less than -6. 0 diopters (d) with less than or equal to 1. 0 d of astigmatism; in patients with documentation of a stable manifest refraction (+-0. 5d) over the prior one year; and in patients who are 18 years of age or older.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S002 S003 S005 S008 S009 S012 
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