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BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM

FDA premarket approval P990027/S010 · decided 2010-05-18

Approval details

PMA number
P990027
Supplement
S010
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
BAUSCH & LOMB TECHNOLAS T217Z ZYOPTIX LASER SYSTEM
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2008-08-11
Decision date
2010-05-18
Days to decision
645 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
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)

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510(k) clearances by this applicant

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