FDA.reportPublic FDA data

PMA P030008S031

Device
WaveLight EX500 Laser
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S031
Product code
LZS
Decision date
2020-08-21
Generic name
Excimer laser system
Approval order statement
Approval for software changes on the WaveLight® EX500 and the associated WaveNet Planning Software (WPS) to include enhanced WaveFront Optimized (eWFO) treatment with finer adjustment steps for targeted refraction and targeted optical zone.

Current openFDA PMA Record#

Device
WaveLight EX500 Laser
Applicant
Alcon Laboratories, Inc.
PMA number
P030008
Supplement
S031
Product code
LZS
Generic name
Excimer laser system
Decision date
2020-08-21
Decision code
APPR
Date received
2020-02-25
Supplement type
Normal 180 Day Track
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval for software changes on the WaveLight® EX500 and the associated WaveNet Planning Software (WPS) to include enhanced WaveFront Optimized (eWFO) treatment with finer adjustment steps for targeted refraction and targeted optical zone.