PMA P030008S038

Device
WaveLight EX500 Laser
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S038
Product code
LZS
Decision date
2024-02-15
Classification
Ophthalmic
Generic name
Excimer laser system
Approval order statement
hardware design changes for the WaveLight Ex500 Laser

Current openFDA PMA Record#

Device
WaveLight EX500 Laser
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S038
Product code
LZS
Generic name
Excimer laser system
Decision date
2024-02-15
Decision code
APPR
Date received
2023-09-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
hardware design changes for the WaveLight Ex500 Laser