PMA P030008

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S035
Product code
LZS
Decision date
2025-01-16
Generic name
Excimer laser system
Approval order statement
Approval for an alternate joystick in the Patient Bed Swivel 1125 of the WaveLight EX500 Laser System

Current openFDA PMA Record#

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S039
Product code
LZS
Generic name
Excimer laser system
Decision date
2025-01-16
Decision code
APPR
Date received
2024-10-22
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for an alternate joystick in the Patient Bed Swivel 1125 of the WaveLight EX500 Laser System