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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; 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 NumberS055
Date Received04/17/2026
Decision Date06/08/2026
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 a change in the routine Ethylene Oxide sterilization process parameters, specifically a reduction in the Ethylene Oxide gas concentration used to terminally sterilize the subject devices
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