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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/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.
Generic Nameexcimer laser system
6903 university blvd.,
winter park, FL 32792
PMA NumberP980008
Date Received03/19/1998
Decision Date11/12/1999
Product Code LZS 
Docket Number 00M-1231
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
Supplements:  S002 S003 S005 S008 S009 S012