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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 NumberS020
Date Received05/27/2005
Decision Date05/01/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0323
Notice Date 08/17/2006
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 and the ladar 6000 excimer laser system. These devices use a 6. 5 mm optical zone and a 9. 0 treatment zone and are indicated for wave-front guided customcornea laser assisted in-situ keratomileusis (lasik): 1) for the reduction or elimination of hyperopia and hyperopic astigmatism of +0. 75 d to less that +5. 00 d of sphere with up to -3. 00 d of cylinder (which has a magnitude less than or equal to the sphere in minus cylinder convention) and up to +5. 00 cycloplegic spherical equivalent at the spectacle plane; 2) in patients 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. 50 d.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2