Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | STAR Excimer Laser System |
Generic Name | Excimer laser system |
Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
PMA Number | P930016 |
Supplement Number | S054 |
Date Received | 12/01/2017 |
Decision Date | 02/09/2018 |
Product Code |
LZS |
Advisory Committee |
Ophthalmic |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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). |
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