• 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 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
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS020
Date Received09/21/2004
Decision Date03/17/2005
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 05M-0151
Notice Date 04/19/2005
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 visx star s4 ir excimer laser system with vss and wavescan wavefront system. The device uses a 6. 0 mm optical zone, a 9. 0 mm treatment zone, and is indicated for wavefront-guided laser assisted in situ keratomileusis (lasik): 1) for the reduction or ee and the cylinder and sphere have opposite signs; 2) in patients 21 years of ath cylinder and sphere components) for at least one year prior to the date of pre-operative examination.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling