Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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
 
DeviceDISHLER EXCIMER LASER SYSTEMS
ApplicantDtc Eye Surgery Center
8400 E. Prentice Ave.
Suite 1200
Englewood, CO 80111
PMA NumberP970049
Date Received10/06/1997
Decision Date12/16/1999
Withdrawal Date04/11/2002
Docket Number 01M-0043
Notice Date 02/05/2001
Advisory Committee Neurology
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
-
-