• 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 has supplements. The device description may have changed. Be sure to look at the supplements 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 NumberP990010
Date Received02/23/1999
Decision Date11/19/1999
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1447
Notice Date 08/18/2000
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the VISX Excimer Laser System Model C (STAR S2) which included the right to reference information contained in P930016 from VISX, Inc., of Santa Clara, CA. This device is indicated to perfrom LASIK: 1) in patients 18 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from 0 to -14.0 diopters (D) with or without -0.5 D to -5.0 D of astigmatism; and 2) in patients with documented evidence of a change in manifest refraction of less than or equalto 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of pre-operative examination.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Supplements: S001 S004 S006 S007