MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear
FDA premarket approval P180035 · decided 2019-11-15
Approval details
- PMA number
- P180035
- Trade name
- 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.
- Date received
- 2018-09-04
- Decision date
- 2019-11-15
- Days to decision
- 437 days
- Decision code
- APPR
- Product code
- QIT
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Pleasanton, CA
- 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.
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