PMA P030008S035

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S035
Product code
LZS
Decision date
2021-11-19
Generic name
Excimer laser system
Approval order statement
Approval for a hardware design change to the WaveLight EX500 Laser.

Current openFDA PMA Record#

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S035
Product code
LZS
Generic name
Excimer laser system
Decision date
2021-11-19
Decision code
APPR
Date received
2021-09-02
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for a hardware design change to the WaveLight EX500 Laser.