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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
Generic Nameexcimer laser system
ApplicantAMO Manufacturing USA, LLC
510 cottonwood drive
milpitas, CA 95035
PMA NumberP930016
Supplement NumberS061
Date Received11/25/2019
Decision Date02/14/2020
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 a replacement of a Super Luminescent Diode (SLD) used in the iDESIGN Refractive Studio as a replacement for an SLD that is now obsolete.
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