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TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION

FDA premarket approval P990027/S015 · decided 2010-11-30

Approval details

PMA number
P990027
Supplement
S015
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
TECHNOLAS PERFECT VISION 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2010-06-29
Decision date
2010-11-30
Days to decision
154 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
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 INDI

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510(k) clearances by this applicant

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