PMA P990027S010

Device: BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S010
Product code: LZS
Decision date: 2010-05-18
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: 1) REMOVAL OF A REDUNDANT FLUENCE TEST;2) INTRODUCTION OF A NEW SCANNER SYSTEM FROM GSI TO THE LASER SYSTEM:3) EXTRAPOLATION OF THE WAVEFRONT DATA IN THE DIAGNOSTIC ZYWAVE SOFTWARE;4) NEW ZRS (ZYOPTIX REMOTE SUPPORT) SOFTWARE TO MONITOR THE PERFORMANCE OF THELASER AND DIAGNOSTIC DEVICES REMOTELY VIA THE INTERNET;5) MODIFICATION OF THE ZRS TO INCLUDE TRULINK, AN ENHANCEMENT TO THE ZRS SYSTEM;6) INTRODUCTION OF A NEW OP FIELD ILLUMINATION IN THE LASER SYSTEM;7) CHANGE OF THE VIDEO CHIP IN THE CCD LENSLET CAMERA DMK4002-IR; AND8) CHANGE IN THE SUPPLIER OF THE TEMPERATURE CONTROL UNIT IN THE LASER SYSTEM.

Current openFDA PMA Record#

Device: BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM
Applicant: Technolas Perfect Vision GmbH
PMA number: P990027
Supplement: S010
Product code: LZS
Generic name: Excimer laser system
Decision date: 2010-05-18
Decision code: APPR
Date received: 2008-08-11
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: APPROVAL FOR THE FOLLOWING CHANGES: 1) REMOVAL OF A REDUNDANT FLUENCE TEST;2) INTRODUCTION OF A NEW SCANNER SYSTEM FROM GSI TO THE LASER SYSTEM:3) EXTRAPOLATION OF THE WAVEFRONT DATA IN THE DIAGNOSTIC ZYWAVE SOFTWARE;4) NEW ZRS (ZYOPTIX REMOTE SUPPORT) SOFTWARE TO MONITOR THE PERFORMANCE OF THELASER AND DIAGNOSTIC DEVICES REMOTELY VIA THE INTERNET;5) MODIFICATION OF THE ZRS TO INCLUDE TRULINK, AN ENHANCEMENT TO THE ZRS SYSTEM;6) INTRODUCTION OF A NEW OP FIELD ILLUMINATION IN THE LASER SYSTEM;7) CHANGE OF THE VIDEO CHIP IN THE CCD LENSLET CAMERA DMK4002-IR; AND8) CHANGE IN THE SUPPLIER OF THE TEMPERATURE CONTROL UNIT IN THE LASER SYSTEM.