STAR Excimer Laser System
FDA premarket approval P930016/S054 · decided 2018-02-09
Approval details
- PMA number
- P930016
- Supplement
- S054
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAR Excimer Laser System
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2017-12-01
- Decision date
- 2018-02-09
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- 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 senso
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