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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.
 
DeviceCT LUCIA 621P
Generic Nameintraocular lens
Regulation Number886.3600
ApplicantCarl Zeiss Meditec Production, LLC
1040 S. Vintage Ave., Bldg. A
Ontario, CA 91761
PMA NumberP100016
Supplement NumberS016
Date Received02/10/2023
Decision Date05/09/2023
Product Code HQL 
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 modification of the injector component of the CT LUCIA 621P.
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