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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.
 
DeviceRxSight Light Adjustable Lens and Light Delivery Device
Generic NameLight adjustable lens (LAL) and light delivery device (LDD)
Regulation Number886.3600
ApplicantRxsight, Inc.
100 Columbia
Aliso Viejo, CA 92656
PMA NumberP160055
Supplement NumberS011
Date Received02/27/2020
Decision Date05/21/2020
Product Code PZK 
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  
Approval for the software modifications for Light Delivery Device (LDD) system: (1) Update to allow patient data to be entered and saved prior to treatment session; (2) Update to treatment Summary report format to include 2D barcode, in addition to text File; (3) Update GUI (graphical user interface) display; and (4) Update to the self-test routine to include additional confirmation of power reading prior to treatment.
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