MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear

FDA Premarket Approval P180035

Pre-market Approval Supplement Details

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.

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.
Date Received2018-09-04
Decision Date2019-11-15
PMAP180035
SupplementS
Advisory CommitteeOphthalmic
Expedited ReviewNo
Combination Product No
Applicant Address CooperVision, Inc. 5870 Stoneridge Drive suite 1 pleasanton, CA 94588

Supplemental Filings

Supplement NumberDateSupplement Type
P180035Original Filing
S015 2022-12-19 Normal 180 Day Track No User Fee
S014 2022-12-16 30-day Notice
S013 2022-12-14 30-day Notice
S012 2022-09-30 Normal 180 Day Track No User Fee
S011 2022-08-23 30-day Notice
S010 2022-08-17 30-day Notice
S009 2021-12-29 30-day Notice
S008 2021-03-08 30-day Notice
S007 2021-03-05 30-day Notice
S006 2020-04-17 Real-time Process
S005 2020-02-13 30-day Notice
S004
S003
S002 2020-01-09 30-day Notice
S001 2019-11-29 Normal 180 Day Track No User Fee

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