MyDay (Stenfilcon A) ASPHERE, MyDay (Stenfilcon A) TORIC, MyDay (Stenfilcon A) …
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K191763 FDA 510(k)
- FDA Product Code
- LPL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 886.5925 FDA 510(k)
- Regulation Number
- 886.5925 FDA 510(k)
- Advisory Committee
- Ophthalmic FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
These are soft contact lenses designed for daily wear, classified as Lenses, Soft Contact, Daily Wear. They are intended for the correction of ametropia, including myopia, hyperopia, and astigmatism, in non-diseased eyes with power ranges from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -10.00 diopters. The lenses are manufactured from Stenfilcon A, a hydrophilic material.
The MyDay lenses are supplied as single-use, daily disposable products, intended for use in clinical settings such as ophthalmic practices. They are not sterile upon packaging and must be handled according to standard contact lens hygiene protocols. The lenses are regulated under FDA 510(k) clearance (K191763) and fall under device class 2. No MRI safety information is specified, and storage conditions are not detailed in the provided data.
Frequently asked questions
Are these lenses designed for extended wear, or are they meant to be worn only during the day?
The MyDay lenses are specifically designed for daily wear only, meaning they are intended to be worn for a single day and then discarded. They are not approved for extended or overnight wear.
How are the MyDay lenses supplied, and do they require any special handling before use?
The MyDay lenses are supplied as single-use, daily disposable contact lenses. They are not sterile upon packaging, so they must be handled according to standard contact lens hygiene protocols before use, including proper cleaning and disinfection of the lens case and hands.
What range of prescriptions can these lenses correct, and do they accommodate astigmatism?
The MyDay lenses correct a wide range of prescriptions, including myopia (nearsightedness) and hyperopia (farsightedness), with power ranges from -20.00 to +20.00 diopters. They also include toric designs to address astigmatism, with corrections from -0.25 to -10.00 diopters, as well as multifocal options for presbyopia.
Are these lenses reusable, or are they intended for one-time use only?
These lenses are intended for one-time use only—each lens is designed for a single day of wear and must be discarded after removal. This aligns with their classification as daily disposable contact lenses.
What regulatory pathway was followed for the approval of these lenses, and what class do they fall under?
The MyDay lenses were cleared through the FDA 510(k) pathway, specifically under Traditional Review, and are classified as Class II medical devices. The clearance number is K191763, and they fall under the product code LPL (Lenses, Soft Contact, Daily Wear).
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. Sources consulted: MyDay® toric | CooperVision Practitioner, PDF CooperVision MyDay The MyDay (stenfilcon A) Soft (Hydrophilic) Contact ..., MyDay® | CooperVision Practitioner, PDF MyDay Asphere Disposable Contact Lenses Instructions
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191763 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K191763 24 fields · synced Sep 19, 2026