Methafilcon A Soft Hydrophilic Contact Lenses, Frequency 55, Frequency 55 Uv (t…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K993252 FDA 510(k)
- FDA Product Code
- MVN 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)
Methafilcon A Soft Hydrophilic Contact Lenses are spherical lenses made from a random copolymer of hydroxyethylmethacrylate and methacrylic acid. The material has the ability to absorb water, making the lenses soft and pliable for comfortable wear. These lenses are designed for daily wear and are available in various models including Frequency 55, Frequency 55 UV, and Frequency 55 ASP.
The lenses are supplied as sterile, single-use devices and should be handled according to proper hygiene, cleaning, and storage instructions provided by an eye care practitioner. They are classified as Class II medical devices and have received FDA 510K clearance with the product code MVN. The lenses are available in multiple sizes and models to accommodate different patient needs.
Frequently asked questions
What are Methafilcon A Soft Hydrophilic Contact Lenses made of?
These lenses are spherical lenses made from a random copolymer of hydroxyethylmethacrylate and methacrylic acid. The material has the ability to absorb water, making the lenses soft and pliable for comfortable wear.
How are these contact lenses supplied and what is their intended use?
The lenses are supplied as sterile, single-use devices designed for daily wear. They should be handled according to proper hygiene, cleaning, and storage instructions provided by an eye care practitioner.
What models and sizes are available for these contact lenses?
These lenses are available in multiple models including Frequency 55, Frequency 55 UV, and Frequency 55 ASP, with various sizes to accommodate different patient needs as determined by an eye care professional.
What is the regulatory classification of these contact lenses?
Methafilcon A Soft Hydrophilic Contact Lenses are classified as Class II medical devices and have received FDA 510K clearance with the product code MVN, indicating they are substantially equivalent to other legally marketed devices.
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: PDF Patient Instructions For Frequency 55 (Methafilcon A) Soft (Hydrophilic ..., Methafilcon a Soft Hydrophilic Contact Lenses, Frequency 55, Frequency ..., PDF (methafilcon A) Soft (hydrophilic) Contact Lenses
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K993252 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA 510(k) K993252 24 fields · synced Oct 6, 2026