• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)

  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

New Search Back to Search Results
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 NumberS031
Date Received08/11/2008
Decision Date12/01/2008
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the starpatient's chair. The device, as modified, will he marketed under the trade name star s4ir excimer laser system and is indicated for wave front-guided (wfg) laser assisted insitu 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, andminimum pre-operative myopia in their non-dominant eye at least as great as theirtargeted 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 ofpreoperative examination; and4) with a successful preoperative trial of monovision or history of monovisionexperience.