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BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION

FDA premarket approval P990027/S006 · decided 2003-10-10

Approval details

PMA number
P990027
Supplement
S006
Supplement type
Panel Track
Supplement reason
Change Design/Components/Specifications/Material
Trade name
BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION
Generic name
Excimer laser system
Applicant
Technolas Perfect Vision GmbH
Date received
2002-07-18
Decision date
2003-10-10
Days to decision
449 days
Decision code
APPR
Product code
LZS
Advisory committee
Ophthalmic
Expedited review
No
Location
München
Statement
APPROVAL FOR THE BAUSCH & LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM FOR PERSONALIZED VISION CORRECTION. THE DEVICE USES AN OPTICAL ZONE SIZE BETWEEN 6.0 MM AND 7.0 MM WITH A CONSTANT BLEND ZONE OF .875 MM, AND IS INDICATED FOR WAVEFRONT-GUIDED LASER ASSISTED IN-SITU KERATOMILEUSIS (LASIK): 1) FOR THE REDUCTION OR ELIMINATION OF MYOPIA WITH SPHERE UP TO -7.00 D AND CYLINDER UP TO -3.00 D AND MRSE <=7.50 D AT THE SPECTACLE PLANE; 2) IN PATIENTS WITH DOCUMENTED EVIDENCE OF A CHANGE IN MANIFEST REFRACTION

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