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Valley Contax Single Vision - tisilfocon A

FDA 510(k)

Class II (US FDA 510(k))

510(k) K202860

by Valley Contax, Inc.

Identifiers

510(k) Number
K202860 FDA 510(k)
FDA Product Code
HQD FDA 510(k)
Models / Variants
roflufocon D FDA 510(k)
roflufocon E FDA 510(k)
tisilfocon A FDA 510(k)
hexafocon A FDA 510(k)
enflufocon A FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5916 FDA 510(k)
Regulation Number
886.5916 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Valley Contax lenses are gas permeable contact lenses designed for daily wear. They include single vision (SV), aspheric front multifocal (AFM), and multifocal (VK) variants, each constructed from materials such as roflufocon D, roflufocon E, tisilfocon A, hexafocon A, or enflufocon A. These lenses are intended for correction of refractive errors and vision enhancement in ophthalmic applications.

These lenses are supplied as single-use, non-sterile devices for direct application to the eye. They are classified under product code HQD and fall under FDA 510(k) clearance as Class II devices under special controls. Each variant is available in various prescriptions and diameters, adhering to regulatory standards for contact lens safety and performance.

Frequently asked questions

Are these Valley Contax contact lenses designed for extended wear, or are they meant for daily use only?

These Valley Contax lenses are explicitly designed for daily wear only, as stated in the device description. They are not intended for overnight or extended wear, which is a common distinction from other contact lens types.

Are these Valley Contax lenses single-use, or can they be reused after cleaning?

The lenses are single-use, non-sterile devices, meaning each lens is intended for one-time application to the eye. Reuse is not recommended or supported by the manufacturer, as this could compromise safety and hygiene.

What materials are these Valley Contax lenses made from, and how does that affect their suitability for different prescriptions?

The lenses are constructed from five different gas-permeable materials: roflufocon D, roflufocon E, tisilfocon A, hexafocon A, and enflufocon A. These materials are chosen to provide varying levels of oxygen permeability and optical clarity, allowing them to accommodate a wide range of prescriptions, including single vision (SV), aspheric front multifocal (AFM), and multifocal (VK) designs.

How should these Valley Contax lenses be stored before use, and is there any special handling required?

Since these lenses are non-sterile and single-use, they should be stored in a clean, dry environment away from direct sunlight or extreme temperatures until use. The packaging should remain intact until application to ensure sterility is not compromised. No special handling (like wetting solutions) is required before use, as they are intended for direct application.

What regulatory pathway was followed for these Valley Contax lenses, and what does that mean for their safety and approval?

These lenses were cleared through the FDA’s 510(k) process, specifically under Traditional Review and classified as Class II devices under special controls for ophthalmic use. The clearance type is labeled as *Substantially Equivalent (SESE)*, meaning they meet FDA standards for safety and performance comparable to legally marketed predecessors. The product code HQD further confirms their classification as contact lenses.

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: Valley Contax Single Vision (SV) Gas Permeable Contact Lens (roflufocon ..., PDF K202860 Valley Contax Single Vision (SV) Gas Permeable Contact Lens ..., K202860 FDA 510(k) - Valley Contax Single Vision (SV) Gas Pe...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Valley Contax, Inc.

Sources (1)

  • FDA 510(k) K202860 24 fields · synced Sep 19, 2026