PMA P030008S014

Device
WAVELIGHT EX500 LASER SYSTEM
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S014
Product code
LZS
Decision date
2014-02-20
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.

Current openFDA PMA Record#

Device
WAVELIGHT EX500 LASER SYSTEM
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S014
Product code
LZS
Generic name
Excimer laser system
Decision date
2014-02-20
Decision code
OK30
Date received
2014-01-29
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
ADDITION OF AN ALTERNATE COMPONENT SUPPLIER.