PMA P020050S027

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P020050
Supplement
S027
Product code
LZS
Decision date
2017-12-21
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
Approval for changes to RAS-board by adding two LEDs to ease troubleshooting during manufacturing and service.

Current openFDA PMA Record#

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P020050
Supplement
S027
Product code
LZS
Generic name
Excimer laser system
Decision date
2017-12-21
Decision code
APPR
Date received
2017-09-28
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for changes to RAS-board by adding two LEDs to ease troubleshooting during manufacturing and service.