• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLADARVISION 4000 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
ALCON LABORATORIES
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
-
-