PMA P030008S036

Device
WaveLight EX500 Laser System with Patient Bed Swivel 1125
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S036
Product code
LZS
Decision date
2023-06-02
Classification
Ophthalmic
Generic name
Excimer laser system
Approval order statement
Approval for the modification of ESD-Joystick - Adapter on patient bed

Current openFDA PMA Record#

Device
WaveLight EX500 Laser System with Patient Bed Swivel 1125
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S036
Product code
LZS
Generic name
Excimer laser system
Decision date
2023-06-02
Decision code
APPR
Date received
2023-03-06
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for the modification of ESD-Joystick - Adapter on patient bed