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

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