Fluorex 700 -uv (flusilfocon A), Fluorex 500-Uv (flusilfocon B) And Fluorex 300…
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K991780 FDA 510(k)
- FDA Product Code
- HQD 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 Fluorex rigid gas permeable contact lenses are available in three models: Fluorex 700-Uv (Flusilfocon A), Fluorex 500-Uv (Flusilfocon B), and Fluorex 300-Uv (Flusilfocon C). These lenses are designed for daily wear and are classified as contact lenses made of other materials. They are intended for use as vision correction devices.
The lenses are supplied as sterile devices and are classified as Class II medical devices. They have received FDA 510(k) clearance with K991780 and are regulated under product code HQD. The lenses are manufactured by G.T. Laboratories, Inc. and are available in the specified models with their respective material compositions.
Frequently asked questions
What are the different models of Fluorex rigid gas permeable contact lenses available?
The Fluorex rigid gas permeable contact lenses are available in three models: Fluorex 700-Uv (Flusilfocon A), Fluorex 500-Uv (Flusilfocon B), and Fluorex 300-Uv (Flusilfocon C). Each model has a different material composition while serving the same purpose of vision correction.
How are the Fluorex contact lenses supplied and what is their sterility status?
The Fluorex rigid gas permeable contact lenses are supplied as sterile devices. They are classified as Class II medical devices and are manufactured by G.T. Laboratories, Inc. to ensure sterility and quality standards for patient safety.
What is the regulatory status of the Fluorex contact lenses?
The Fluorex rigid gas permeable contact lenses have received FDA 510(k) clearance with K991780 and are regulated under product code HQD. They are classified as Class II medical devices and are intended for daily wear as vision correction devices.
What are the intended uses of the Fluorex rigid gas permeable contact lenses?
The Fluorex rigid gas permeable contact lenses are designed for daily wear and are classified as contact lenses made of other materials. They are intended for use as vision correction devices for patients requiring such correction.
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_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K991780 | Class II | Active |
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Manufacturer
- Manufacturer
- G.T. Laboratories, Inc.
Sources (1)
- FDA 510(k) K991780 24 fields · synced Oct 1, 2026