PMA P930016S065

Device
STAR S4 IR Excimer Laser
Applicant
Amo Manufacturing USA, LLC
Product code
LZS
Decision date
2024-07-01
Generic name
Excimer laser system
Approval order statement
the replacement of 5 encoders total in both the Beam Shaping Module and the Hyperopia Module, added spacers to accommodate the new encoders, and adjustments to your software to reduce x-axis homing speed

Current openFDA PMA Record#

Device
STAR S4 IR Excimer Laser
Applicant
Amo Manufacturing USA, LLC
PMA number
P930016
Supplement
S065
Product code
LZS
Generic name
Excimer laser system
Decision date
2024-07-01
Decision code
APPR
Date received
2023-12-05
Supplement type
Real-Time Process
Supplement reason
Change Design/Components/Specifications/Material
Approval order statement
the replacement of 5 encoders total in both the Beam Shaping Module and the Hyperopia Module, added spacers to accommodate the new encoders, and adjustments to your software to reduce x-axis homing speed