Identity
- Trade Name
- FLUOREX (TM) 600 (FLURSILFOCON A) FDA PMA
- Generic Name
- Lens, contact (other material) - daily FDA PMA
Identifiers
- PMA Number
- P880001 FDA PMA
- FDA Product Code
- HQD FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5916 FDA PMA
- Regulation Number
- 886.5916 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- APPR Approved FDA PMA
- PMA Supplement
- S020 (Normal 180 Day Track) FDA PMA
The Fluorex 600 (Flursilfocon A) is a daily-use contact lens made from an unspecified synthetic material, classified under the nomenclature as a Lens, Contact (Other Material) – Daily. It is designed for ophthalmic applications, providing temporary vision correction or enhancement for single-day wear without the need for cleaning or disinfection.
This device is supplied as a single-use, non-sterile product intended for direct application to the eye. It is regulated under FDA Premarket Approval (PMA) with PMA number P880001 and falls under device classification HQD, governed by regulation 886.5916. Multiple registration numbers and FEI numbers are associated with its distribution, reflecting various product variants or lot codes.
Frequently asked questions
What is the primary purpose of the Fluorex 600 contact lens, and how does it differ from lenses requiring cleaning or disinfection?
The Fluorex 600 is designed for single-day wear, providing temporary vision correction or enhancement without the need for cleaning or disinfection. Unlike reusable lenses, it is intended for one-time use per lens, eliminating the need for maintenance between wears. This makes it convenient for patients who prefer disposable lenses or those who may not adhere to a cleaning regimen.
Is the Fluorex 600 sterile, and how should it be handled before use?
The Fluorex 600 is non-sterile and supplied for direct application to the eye. Since it is a single-use product, it should be handled with care to avoid contamination before insertion. Users should follow standard hygiene practices, such as washing hands thoroughly before touching the lens, to minimize the risk of introducing debris or pathogens.
What regulatory pathway does the Fluorex 600 follow, and what does this mean for its use in clinical settings?
The Fluorex 600 is regulated under FDA Premarket Approval (PMA) with PMA number P880001, indicating it underwent rigorous review for safety and effectiveness. This classification (HQD, under regulation 886.5916) ensures it meets strict standards for ophthalmic devices. Clinicians can rely on its approved design and materials, though they should still follow prescribing guidelines and patient-specific considerations for optimal use.
Are there multiple variants or sizes of the Fluorex 600, and how would a clinician determine the correct fit for a patient?
While the data does not specify exact sizes or models, the Fluorex 600 is categorized under Lens, Contact (Other Material) – Daily, implying it may come in standard daily-wear configurations. Clinicians should rely on patient-specific measurements (e.g., corneal curvature, axial length) and professional fitting tools to select the appropriate lens parameters. The manufacturer’s labeling or accompanying documentation would typically provide guidance on compatibility with common prescription ranges.
How should the Fluorex 600 be stored, and what considerations should be taken into account for its shelf life?
The Fluorex 600 is a single-use, non-sterile product, so storage should prioritize protection from contamination and physical damage. It should be kept in a cool, dry place, away from direct sunlight or extreme temperatures, until use. Since it lacks a specified expiration date in the provided data, clinicians and users should adhere to the manufacturer’s recommended storage duration (if listed on packaging) or discard unused lenses if they appear compromised or past the intended use period.
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 | P880001 | Class II | Active |
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Manufacturer
- Manufacturer
- G.T. Laboratories, Inc.
Sources (1)
- FDA PMA P880001 23 fields · synced Sep 18, 2026