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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.
 
DeviceiDESIGN Refractive Studio, STAR S4 IR Excimer Laser System
Generic NameExcimer laser system
ApplicantAmo Manufacturing USA, LLC
510 Cottonwood Dr.
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS067
Date Received07/12/2024
Decision Date08/09/2024
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P930016/S053.
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