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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.
 
DeviceEuclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantEuclid Vision Corporation
45472 Holiday Dr.
Suite 7
Sterling, VA 20166
PMA NumberP040029
Supplement NumberS023
Date Received06/28/2024
Decision Date05/23/2025
Product Code NUU 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for additional models (brandings) and updated instructions for use for Euclid Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear lenses.
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