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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 (LAL) 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 NumberS002
Date Received09/05/2018
Decision Date03/04/2019
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 post-approval study protocol, RxSight Light Adjustable Lens (LAL) and Light Delivery Device (LDD) New Enrollment Study, and modifications to the LAL posterior layer, the LAL haptic attachment manufacturing process, and the LDD light source, table configuration, infrared anterior segment illumination, and contact lens.
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