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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.
 
DeviceClearView™ HD intraocular lens (IOL)
Generic NameLens, multifocal intraocular
Regulation Number886.3600
ApplicantLenstec, Inc.
1765 Commerce Ave. N
St. Petersburg, FL 33716
PMA NumberP200020
Supplement NumberS013
Date Received04/17/2026
Decision Date10/23/2026
Product Code MFK 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for the ClearView™ HD Intraocular Lens (IOL) as a combination of the haptic design of the ClearView™ 3 IOL with the optical design of the Softec HD IOL
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