- Device
- STAR Excimer Laser System
- Applicant
- Amo Manufacturing USA, LLC
- PMA number
- P930016
- Supplement
- S054
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 2018-02-09
- Decision code
- APPR
- Date received
- 2017-12-01
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- Approval for 1) the replacement of the existing photo interrupter (3703-0124, manufactured by Hamamatsu) in the Hyperopia Moving assembly (0030-2166) used in the Hyperopia Module (0030-3593) of the STAR S4 IR, with a replacement photo interrupter (3703-0157-L, manufactured by Sharp Microelectronics);2) the replacement of the existing Hall Effect sensor (sensor) (SS21PE) used in the L2 Rotating Cable Assembly (0030-2714) of the STAR S4 IR L2 Rotating Assembly (0030-2508), with a replacement sensor (0035-1010); and 3) the replacement of the existing L2 Cable (0030-2714), with a replacement cable (0030-2035).