PMA P030008S016

Device
WAVELIGHT EX500 LASER SYSTEM
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S016
Product code
LZS
Decision date
2015-01-20
Classification
Excimer Laser System
Generic name
Excimer laser system
Approval order statement
APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM.

Current openFDA PMA Record#

Device
WAVELIGHT EX500 LASER SYSTEM
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S016
Product code
LZS
Generic name
Excimer laser system
Decision date
2015-01-20
Decision code
APPR
Date received
2014-10-23
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
APPROVAL FOR A NEW SOFTWARE RELEASE FOR THE WAVELIGHT® EX500 EXCIMER LASER SYSTEM.