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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 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 NumberS038
Date Received05/01/2024
Decision Date07/29/2024
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 an extension of the spherical refractive power range of -2.0 to +3.0 D in one diopter (D) increments for the Light Adjustable Lens (LAL) model LAL+ intraocular lens (IOL) for use with the Light Delivery Device (LDD) model 61002-007
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