PMA P990027S009

Device
BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
Applicant
Technolas Perfect Vision GmbH
PMA number
P990027
Supplement
S009
Product code
LZS
Decision date
2008-02-01
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
APPROVAL FOR THE EXPANSION OF THE PHYSICIAN ADJUSTMENT RANGE FOR THE SPHERICAL COMPONENT ROM +2.5 D TO -1.0 D.

Current openFDA PMA Record#

Device
BAUSCH& LOMB TECHNOLAS 217Z ZYOPTIX SYSTEM
Applicant
Technolas Perfect Vision GmbH
PMA number
P990027
Supplement
S009
Product code
LZS
Generic name
Excimer laser system
Decision date
2008-02-01
Decision code
APPR
Date received
2006-12-19
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR THE EXPANSION OF THE PHYSICIAN ADJUSTMENT RANGE FOR THE SPHERICAL COMPONENT ROM +2.5 D TO -1.0 D.