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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
Classification Nameexcimer laser system
Generic Nameexcimer laser system
6201 s freeway
ft worth, TX 76134
PMA NumberP970043
Supplement NumberS007
Date Received09/03/1999
Decision Date09/22/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1612
Notice Date 11/21/2000
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? Yes
Combination Product No
Approval Order Statement 
Approval for the ladarvision(r) excimer laser system. The device is indicated for laser in-situ keratomileusis (lasik) treatments: 1) for the reduction or eliminatino of refractive error of less than or equal to +6. 00d of sphere and -6. 00d of cylinder at the spectacle plane (hyperopia with or without astigmatism and mixed astigmatism); 1) in subjects 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 +6. 00d se; and, 3) in subjects who are 21 years of age or older.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling