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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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.
 
DeviceSTAR Excimer Laser System
Generic Nameexcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS054
Date Received12/01/2017
Decision Date02/09/2018
Product Code LZS 
Advisory Committee Ophthalmic
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination ProductNo
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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