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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceFINEVISION HP Trifocal IOLs
Generic Nameintraocular lens
ApplicantBeaver Visitec International, Inc.
500 Totten Pond Rd.
Waltham, MA 02451
PMA NumberP240038
Date Received10/30/2024
Decision Date09/10/2025
Product Codes HQL MFK 
Docket Number FDA-3951
Notice Date 09/17/2025
Advisory Committee Ophthalmic
Clinical TrialsNCT04176965
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the FINEVISION HP Trifocal Intraocular Lens (IOL). The FlNEVISION HP Trifocal intraocular Lens is indicated for primary implantation in the capsular bag in the posterior chamber of the eye for the visual correction of aphakia in adult patients, with less than 1 diopter of pre-existing corneal astigmatism, in whom a cataractous lens has been removed by phacoemulsification. The lens mitigates the effects of presbyopia by providing improved intermediate and near visual acuity, while maintaining comparable distance visual acuity compared to a monofocal IOL.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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