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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 & WAVESCAN SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantVISX, INCORPORATED
PMA NumberP930016
Supplement NumberS025
Date Received09/29/2006
Decision Date07/11/2007
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 07M-0288
Notice Date 07/20/2007
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 variable spot scanning (vss) and wavescan wavefront system. The device used 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) to achieve monovision by the targeted retention of myopia (-1. 25 to -2. 00 d) in the non-dominant eye of presbyopic myopes: 1) 40 years or older who may benefit from increased spectacle independence across a range of distances with useful near vision; 2) with myopic astigmatism up to -6. 00 d mrse, with cylinder up to -3. 00 d, and minimum pre-operative myopia in their non-dominant eye at least as great as their targeted myopia; 3) 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; and 4) with a successful pre-operative trial of monovision or history of monovision experience.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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