Identity
- Trade Name
- MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear FDA PMA
- Generic Name
- Daily wear soft contact lens to reduce the progression of myopia FDA PMA
Identifiers
- PMA Number
- P180035 FDA PMA
- FDA Product Code
- QIT FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
MiSight 1 Day (omafilcon A) is a daily wear soft contact lens designed to correct myopic ametropia and slow the progression of myopia in children. It is indicated for use in children aged 8-12 years with non-diseased eyes and a spherical equivalent refraction of -0.75 to -4.00 diopters with up to 0.75 diopters of astigmatism.
The lens is made of omafilcon A material and is intended for single-use daily wear, to be discarded after each removal. It is authorized under FDA PMA P180035 and manufactured by CooperVision, Inc. in Pleasanton, CA.
Frequently asked questions
What is the intended use of MiSight 1 Day (omafilcon A) contact lenses?
MiSight 1 Day (omafilcon A) contact lenses are indicated for the correction of myopic ametropia and for slowing the progression of myopia in children aged 8-12 years with non-diseased eyes, a spherical equivalent refraction of -0.75 to -4.00 diopters, and up to 0.75 diopters of astigmatism.
How often should MiSight 1 Day lenses be replaced?
MiSight 1 Day lenses are designed for single-use daily wear and must be discarded after each removal, as specified in the approval statement.
Who manufactures MiSight 1 Day (omafilcon A) contact lenses?
MiSight 1 Day (omafilcon A) contact lenses are manufactured by CooperVision, Inc., located at 5870 Stoneridge Dr., Suite 1, Pleasanton, CA 94588.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P180035 | Class III | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P180035 24 fields · synced Sep 18, 2026