PMA P020050S041

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P020050
Supplement
S041
Product code
LZS
Decision date
2023-08-23
Classification
Ophthalmic
Generic name
Excimer laser system
Approval order statement
Approval to replace the Operation Microscope Zoom (OPMI Zoom) supplied by company Carl Zeiss with an equivalent microscope (MIC-EX) supplied by ATMOS MedizinTechnik.

Current openFDA PMA Record#

Device
WaveLight EX500 Laser System
Applicant
Alcon Laboratories, Inc.
PMA number
P020050
Supplement
S041
Product code
LZS
Generic name
Excimer laser system
Decision date
2023-08-23
Decision code
APPR
Date received
2023-05-26
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
Approval to replace the Operation Microscope Zoom (OPMI Zoom) supplied by company Carl Zeiss with an equivalent microscope (MIC-EX) supplied by ATMOS MedizinTechnik.