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 NameLADARVISION EXCIMER LASER SYSTEM
Classification Nameexcimer laser system
Generic Nameophthalmic excimer laser system
ApplicantSUMMIT AUTONOMOUS, INC.
PMA NumberP970043
Supplement NumberS005
Date Received09/03/1999
Decision Date05/09/2000
Product Code
LZS[ Registered Establishments with LZS ]
Docket Number 00M-1593
Notice Date 11/14/2000
Advisory Committee Ophthalmic
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the ladarvision excimer laser system indicated for laser in-situ keratomileusis (lasik).
Approval Order Approval Order
-
-