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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.
 
Trade NameLADARVISION 4000 EXCIMER LASER SYSTEM AND THE LADAR 6000 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantALCON LABORATORIES,INC
PMA NumberP970043
Supplement NumberS022
Date Received11/03/2005
Decision Date05/02/2006
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 06M-0324
Notice Date 08/17/2006
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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 mixed astigmatism 1. 00 d to less than 5. 00 d cycloplegic cylinder magnitude at the spectacle plane, which is greater than the sphere magnitude, and the cylinder and sphere have opposite signs; 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
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