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) | Registration & Listing | Adverse Events | Recalls | PMA | 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.
 
Trade NameEC-5000 EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
ApplicantNIDEK TECHNOLOGIES, INC.
PMA NumberP970053
Supplement NumberS003
Date Received04/28/2000
Decision Date10/25/2000
Product Code
LZS[ Registered Establishments with LZS ]
Advisory Committee Ophthalmic
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - software
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the incorporation of the nomogram for laser in-situ keratomileusis (lasik) treatments into the nidek ec-5000 software, along with the nomogram for prk for moderate myopia with astigmatism.
-
-