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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 system
AMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS017
Date Received11/28/2003
Decision Date12/14/2004
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 05M-0055
Notice Date 02/09/2005
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 star s4 excimer laser system with variable spot scanning (vss) and wavescan wavefront system. The device uses a 6. 00 mm optical zone, a 9. 00 mm treatment zone, and is indicated for wavefront-guided laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of hyperopia an d hyperopic astigmatism up to 3. 00 d mrse, with cylinder between 0. 00 and 2. 00 d; 2) in patients 21 years of age or older; and 3) in patients with documented evidence of a change in manifest refraction of no more than 1. 0 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