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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: Ligh 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 NumberS006
Date Received05/23/2019
Decision Date06/20/2019
Product Code PZK 
Advisory Committee Ophthalmic
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Use alternate manufacturing tools to manufacture the Light Adjustable Lens.
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