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

FDA premarket approval P180035 · Daily wear soft contact lens to reduce the progression of myopia

PMA numberP180035

Approval

Applicant
CooperVision, Inc.
Received
September 4, 2018
Decision date
November 15, 2019 (APPR)
Supplements
34, latest February 17, 2026
Product code
QIT – Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia

Official FDA PMA record

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.