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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 IR EXCIMER LASER SYSTEM WITH VARIABLE SPOT SCANNING (VSS) AND WAVESCAN WAVEFRONT SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS021
Date Received03/08/2005
Decision Date08/30/2005
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 05M-0382
Notice Date 09/23/2005
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
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 ir excimer laser system with vss and wavescan wavefront system. The device uses a 6. 0 mm optical zone, an 8. 0 mm treatment zone, and is indicated for wavefront-guided (wfg) laser assisted in situ keratomileusis (lasik): 1) for the reduction or elimination of myopia and myopic astigmatism from -6. 0 to -11. 00 d mrse, with cylinder between 0. 00 and -3. 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. 00 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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