FDA.reportPublic FDA data

PMA P030008S024

Device
Wave Light EX500 Laser
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S024
Product code
LZS
Decision date
2018-04-09
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
Approval for modification of the electronic circuit of VSE (Versorgungseinheit or supply unit) board in the WaveLight EX500 system by adding resistor-capacitor circuits to the switch transistors to reduce the starting currents and improve the reliability and life of the board.

Current openFDA PMA Record#

Device
Wave Light EX500 Laser
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S024
Product code
LZS
Generic name
Excimer laser system
Decision date
2018-04-09
Decision code
APPR
Date received
2018-01-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for modification of the electronic circuit of VSE (Versorgungseinheit or supply unit) board in the WaveLight EX500 system by adding resistor-capacitor circuits to the switch transistors to reduce the starting currents and improve the reliability and life of the board.