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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.
 
DeviceIC-8 Apthera Intraocular Lens (IOL)
Generic NameExtended depth of focus intraocular lens
Regulation Number886.3600
ApplicantAcu Focus, Inc.
32 Discovery Suite 200
Irvine, CA 92618
PMA NumberP210005
Supplement NumberS007
Date Received12/06/2024
Decision Date04/25/2025
Product Code POE 
Advisory Committee Ophthalmic
Clinical TrialsNCT05758883
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - PAS
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for updating the Instructions for Use of the IC-8 Apthera Intraocular Lens (IOL) to include the outcomes of the Continuation Post-Approval Study (PAS) SAIL-101-PAS
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