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 PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Generic NameExcimer laser system
ApplicantTECHNOLAS PERFECT VISION GMBH
MESSERSCHMITTSTR 1 + 3
MUNCHEN 80992
PMA NumberP990027
Supplement NumberS015
Date Received06/29/2010
Decision Date11/30/2010
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR THE ADVANCED NOMOGRAM SOFTWARE MODULE AS AN UPGRADE TO THE EXISTING SOFTWARE OF THE TECHNOLAS PERFECT VISION® 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION. THE ADVANCED NOMOGRAM RESIDES ON A SEPARATE COMPUTER WITH THE ZYLINK TREATMENTCALCULATION SOFTWARE, AND IT LEAVES ALL HARDWARE COMPONENTS AND THE LASER BEAM CONTROL SOFTWARE MODULE UNCHANGED. THE TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZEDVISION CORRECTION WITH ADVANCED NOMOGRAM SOFTWARE MODULE IS INDICATED FOR WAVEFRONT-GUIDEDLASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK):1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO-3.00 D AND MRSE <=7.50 D AT THE SPECTACLE PLANE;2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION OF LESS THAN OREQUAL TO +-0.50 DIOPTERS (IN BOTH CYLINDER AND SPHERE COMPONENTS) FOR AT LEAST ONE YEARPRIOR TO THE DATE OF THE PRE-OPERATIVE EXAMINATION; AND3) IN PATIENTS 21 YEARS OF AGE OR OLDER.
-
-