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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceMiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
Generic NameDaily wear soft contact lens to reduce the progression of myopia
ApplicantCooperVision, Inc.
5870 Stoneridge Dr., Suite 1
Pleasanton, CA 94588
PMA NumberP180035
Date Received09/04/2018
Decision Date11/15/2019
Product Code QIT 
Docket Number 19M-5438
Notice Date 11/19/2019
Advisory Committee Ophthalmic
Clinical TrialsNCT01729208
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements:  S001 S002 S003 S004 S016 S017 S007 S008 S009 S012 S024 
S026 S027 S030 S021 S006 S005 S013 S014 S015 S018 S019 S010 
S011 S028 S029 S025 S031 S022 S023 S020 S032 S033 S034 
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