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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.
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
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
Recalls CDRH Recalls
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