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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 NameVISX STAR S4 IR EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameexcimer laser for ophthalmic use
ApplicantABBOTT MEDICAL OPTICS INC
PMA NumberP930016
Supplement NumberS031
Date Received08/13/2008
Decision Date12/01/2008
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the star patient's chair. The device, as modified, will he marketed under the trade name star s4 ir excimer laser system and is indicated for wave front-guided (wfg) laser assisted in situ keratomileusis (las1k) 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 preoperative examination; and 4) with a successful preoperative trial of monovision or history of monovision experience.
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