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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 (iDesign/G301)
Generic NameExcimer laser system
ApplicantAmo Manufacturing USA, LLC
510 Cottonwood Dr.
Milpitas, CA 95035
PMA NumberP930016
Supplement NumberS064
Date Received12/05/2023
Decision Date03/21/2024
Product Code LZS 
Advisory Committee Ophthalmic
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Requested approval for a material change to the forehead strap and chin rest of the iDesign System (P930016/S053).
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