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Device | Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear |
Generic Name | Lens, contact, orthokeratology, overnight |
Regulation Number | 886.5916 |
Applicant | Euclid Vision Corporation 45472 Holiday Drive Suite 7 Sterling, VA 20166 |
PMA Number | P040029 |
Supplement Number | S017 |
Date Received | 10/09/2020 |
Decision Date | 03/30/2021 |
Product Code |
NUU |
Advisory Committee |
Ophthalmic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for model name additions to the Euclid Systems Orthokeratology (tisilfocon A) Contact Lenses for Overnight Wear |