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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 NumberS005
Date Received05/08/2019
Decision Date08/06/2019
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 addition of a barcode scanner, internalization of the (optional) external LDD camera and update to the red reticle to enhance LAL visualization and alignment monitoring (called Align Assist), addition of an alternate supplier and model for the system computer and graphics card, and modification to LDD table legs to meet pinch point IEC 60601-1 testing requirements.
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