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
Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTECHNOLAS 217A EXCIMER LASER SYSTEM
Generic NameExcimer laser system
ApplicantTechnolas Perfect Vision GmbH
Messerschmittstr. 1+ 3
München 80992
PMA NumberP990027
Supplement NumberS013
Date Received10/01/2009
Decision Date11/04/2009
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR SOFTWARE CHANGES INTRODUCED IN SOFTWARE VERSION 4.23A THAT AFFECTED THE ERROR MESSAGE DISPLAYS DURING THE CONDITIONING, ENERGY VERIFICATION, ANDTREATMENT PHASES. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMETECHNOLAS T217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTIONOR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00D AND CYLINDER UP TO -3.00D AND MRSE <=7.50D AT THE SPECTACLE PLANE.
-
-