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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.
 
DeviceSTAR S4 ACTIVETRAK EXCIMER LASER SYSTEM AND WAVESCAN WAVEFRONT SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser system
Applicant
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
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/material
Expedited Review Granted? No
Combination Product No
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
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
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