FDA.reportPublic FDA data

PMA P020050S029

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P020050
Supplement
S029
Product code
LZS
Decision date
2018-05-11
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
Approval for Platform Enhancement Refractive Suite Phase I (“PERS I”) hardware changes (color concept, update to head-up display, keyboard, control panel and console updates), and include software release Green SP4 (SP = Service Pack) with changes to the graphical user interface.

Current openFDA PMA Record#

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P020050
Supplement
S029
Product code
LZS
Generic name
Excimer laser system
Decision date
2018-05-11
Decision code
APPR
Date received
2018-02-27
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for Platform Enhancement Refractive Suite Phase I (“PERS I”) hardware changes (color concept, update to head-up display, keyboard, control panel and console updates), and include software release Green SP4 (SP = Service Pack) with changes to the graphical user interface.