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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 NumberS010
Date Received03/18/2002
Decision Date10/18/2002
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 02M-0487
Notice Date 11/18/2002
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ladarvision 4000 excimer laser system. This device uses a 6. 5 mm optical zone, a 9. 0 mm treatment zone, is locked-out for treatments above -7. 0 diopters (d) as measured by manifest refraction, and is indicated for wavefront-guided laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of myopia up to -7. 00 d with less than -0. 50 d of astigmatism at the spectacle plane; 2) in patients who are 21 years of age or older; and 3) in patients with documented stability of refraction for the prior 12 months, as demonstrated by a change of less than or equal to 0. 50 d.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2