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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 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS016
Date Received10/01/2002
Decision Date05/23/2003
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 03M-0333
Notice Date 07/30/2003
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the vixx star s4 activetrak excimer laser system and wavescan wavefront system. The device uses a 6. 00 mm optical zone, an 8. 00 mm treatment zone, and is indicated for wavefront-guided laser assisted in situ keratomileusis (lasik) for: 1) the reduction or elimination of myopic astigmatism up to -6. 00 d mrse, with cylinder between 0. 00 and -3. 00 d; 2) patients 21 years of age or older; and 3) patients with documented evidence of a change in manifest refraction of no more than 0. 50 d (in both 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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