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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 Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisil
Generic NameLens, contact, orthokeratology, overnight
Regulation Number886.5916
ApplicantEuclid Vision Corporation
45472 Holiday Drive
Suite 7
Sterling, VA 20166
PMA NumberP040029
Supplement NumberS016
Date Received08/12/2020
Decision Date02/04/2021
Product Code NUU 
Advisory Committee Ophthalmic
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for model name additions to the Euclid Systems Orthokeratology (oprifocon A) Contact Lenses for Overnight Wear and Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear
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