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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 NameSTAR S4 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS)
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
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
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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
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