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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 NumberS027
Date Received08/08/2007
Decision Date11/09/2007
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the upgrade star software version 5. 21, star software version 5. 22 and the wavescan wavefront system software version 3. 671. The devices, as modified, will be marketed under the trade names star s4 ir excimer laser system with variable spot scanning (vss) and wavescan wavefront system and are indicated for wavefront-guided (wfg) laser assisted in situ keratimileusis (lasik) to achieve 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.