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Device | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear |
Generic Name | Daily wear soft contact lens to reduce the progression of myopia |
Applicant | CooperVision, Inc. 5870 Stoneridge Drive Suite 1 Pleasanton, CA 94588 |
PMA Number | P180035 |
Date Received | 09/04/2018 |
Decision Date | 11/15/2019 |
Product Code |
QIT |
Docket Number | 19M-5438 |
Notice Date | 11/19/2019 |
Advisory Committee |
Ophthalmic |
Clinical Trials | NCT01729208
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Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear. This device indicated for the correction of myopic ametropia and for slowing the progression of myopia in children with non-diseased eyes, who at the initiation of treatment are 8-12 years of age and have a refraction of -0.75 to -4.00 diopters (spherical equivalent) with less than or equal to 0.75 diopters of astigmatism. The lens is to be discarded after each removal. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling Labeling Part 2 |
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S003 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S014 S015 S016 S017 S018 S019 S020 S021 S022 S023 S024 |