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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 NumberS010
Date Received05/09/2025
Decision Date07/14/2026
Product Code POE 
Advisory Committee Ophthalmic
Clinical TrialsNCT06060041
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for continuing to conduct the PAS2 study under the currently approved protocol, SAIL-101-PAS2 Protocol Version 3.2, as approved under P210005/S004
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