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TECHNOLAS 217A EXCIMER LASER SYSTEM

FDA premarket approval P990027/S013 · decided 2009-11-04

Approval details

PMA number
P990027
Supplement
S013
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Trade name
TECHNOLAS 217A EXCIMER LASER SYSTEM
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2009-10-01
Decision date
2009-11-04
Days to decision
34 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
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

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510(k) clearances by this applicant

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VICTUS Femtosecond Laser Platform (K171014)Technolas Perfect Vision GmbH2017-10-19
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VICTUS FEMTOSECOND LASER PLATFORM (K141379)Technolas Perfect Vision GmbH2015-01-16
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VICTUS FEMTOSECOND LASER PLATFORM (K122386)Technolas Perfect Vision GmbH2013-02-08
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