PMA P930016S051

Device: Star S4 IR Excimer Laser System
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S051
Product code: LZS
Decision date: 2017-07-14
Classification: Excimer Laser System
Generic name: Excimer laser system
Approval order statement: Approval for the replacement of the existing photo interrupter (3703-0124, manufactured by Hamamatsu) in the BSM Flex assembly (0030-1275) used in the Beam Shaping Module (BSM) assembly (0030-2162) of the STAR S4 IR, with a replacement photo interrupter (3703-0157-L, manufactured by Sharp Microelectronics).

Current openFDA PMA Record#

Device: Star S4 IR Excimer Laser System
Applicant: Amo Manufacturing USA, LLC
PMA number: P930016
Supplement: S051
Product code: LZS
Generic name: Excimer laser system
Decision date: 2017-07-14
Decision code: APPR
Date received: 2017-05-16
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the replacement of the existing photo interrupter (3703-0124, manufactured by Hamamatsu) in the BSM Flex assembly (0030-1275) used in the Beam Shaping Module (BSM) assembly (0030-2162) of the STAR S4 IR, with a replacement photo interrupter (3703-0157-L, manufactured by Sharp Microelectronics).