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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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DeviceOptimum Infinite (tisilfocon A) Orthokeratology Lenses II
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantContamac, Ltd.
Carlton House
Shire Hill
Saffron Walden CB11 3AU
PMA NumberP240045
Date Received12/17/2024
Decision Date02/10/2026
Product Code NUU 
Advisory Committee Ophthalmic
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for Optimum Infinite (tisilfocon A) Ortho-k Lenses, Optimum Infinite (tisilfocon A) Orthokeratology Lenses II.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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