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