• 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
8400 east prentice ave.
suite 1200
englewood, CO 80111
PMA NumberP970049
Date Received10/06/1997
Decision Date12/16/1999
Withdrawal Date 04/11/2002
Docket Number 01M-0043
Notice Date 02/05/2001
Advisory Committee Neurology
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for LASIK in patients 21 years of age or older in treatments for the reduction or elimination of myopia (nearsightedness) from -0.5 to -13.0 diopters (D) MRSE (manifest refraction spherical equivalence) with or without -0.5 D to - 4.0 D astigmatism; and in patients with documented evidence of changes refraction of less than or equal to 0.5 D (in both cylinder and sphere components) per year for at least one year prior to the date of preoperative examination.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling