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BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM

FDA premarket approval P990027/S011 · decided 2009-05-01

Approval details

PMA number
P990027
Supplement
S011
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2008-09-03
Decision date
2009-05-01
Days to decision
240 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
Statement
APPROVAL FOR THE DYNAMIC ROTATIONAL EYE TRACKER WITH IRIS RECOGNITION FOR USE WITH THE BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISIONCORRECTION. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TECHNOLAS 217Z ZYOPTIX LASER SYSTEM FOR PERSONALIZED VISION CORRECTION AND IS INDICATED FOR:1) WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK) TREATMENTS FOR THE REDUCTION ORELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO -3.00 D A

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