PMA P030008S039

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S039
Product code
LZS
Decision date
2025-01-16
Classification
Ophthalmic
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