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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 NumberS015
Date Received09/30/2003
Decision Date06/29/2004
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 04M-0312
Notice Date 07/16/2004
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ladarvision 4000 excimer laser system. The device uses a 6. 5 mm optical zone, a 9. 00 mm ablation zone, is locked-out for treatments above -9. 75 diopters (d) sphere, -5. 00d cylinder, and -10. 63d spherical equivalent (se), and is indicated for wavefront-guided laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of myopic astigmatism up to -8. 00d sphere with -0. 50 to -4. 00d cylinder and up to -8. 00d se 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 in sphere and cylinder of less than or equal to 0. 50d for a se of up to -6. 00d and less than or equal to 0. 75d for a se greater than -6. 00d.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling