PMA P030008S020

Device
WAVELIGHT EX500 LASER SYSTEM
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S020
Product code
LZS
Decision date
2015-05-05
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
QUALIFY AN ALTERNATE SUPPLIER FOR CALIBRATION TARGETS USED FOR THE WAVELIGHT EX500 LASER SYSTEM.

Current openFDA PMA Record#

Device
WAVELIGHT EX500 LASER SYSTEM
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S020
Product code
LZS
Generic name
Excimer laser system
Decision date
2015-05-05
Decision code
OK30
Date received
2015-04-09
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
QUALIFY AN ALTERNATE SUPPLIER FOR CALIBRATION TARGETS USED FOR THE WAVELIGHT EX500 LASER SYSTEM.