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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.
 
DeviceLight Adjustable Lens, 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 NumberS022
Date Received10/28/2021
Decision Date01/31/2023
Product Code PZK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the following modifications: 1) reducing the LDD footprint (i.e., making the LDD system more compact in a different physical configuration); 2) converting the operating system to Linux; 3) modifying the graphic user interface for better patient data entry; 4) updating the LDD work instructions based on the modified LDD; and 5) and modifications to the labeling.
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