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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
ApplicantAMO Manufacturing USA, LLC
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
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
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