Fluoroperm (paflufocon A) Rgp Contact Lens
FDA PMAClass II (US FDA PMA)
Identity
- Trade Name
- FLUOROPERM RGP CONTACT LENSES FDA PMA
- Generic Name
- Lens, contact (rigid gas permeable), extended wear FDA PMA
Identifiers
- PMA Number
- P870024 FDA PMA
- FDA Product Code
- MWL FDA PMA
Classification
- Device Class
- Class III 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
The Fluorperm PAFLUFOCON A is a rigid gas permeable (RGP) contact lens designed for extended wear. Classified as a Lens, Contact (Rigid Gas Permeable), Extended Wear, it is intended for corneal reshaping and continuous overnight wear under medical supervision. Its construction allows for oxygen permeability, supporting prolonged contact with the eye while maintaining corneal health. The lens is formulated with PAFLUFOCON A, a proprietary material intended to enhance comfort and stability during extended use.
This device is supplied as a single-use or multi-use lens, depending on clinical protocol, and requires professional fitting by an eye care practitioner. It is not sterile at the point of sale but must be handled under aseptic conditions before use. The lens is regulated under FDA PMA (Pre-Market Approval) P870024, with supplementary updates (e.g., S001, S011) addressing design modifications. Compliance with 21 CFR 886.5916 ensures adherence to safety and performance standards for extended-wear contact lenses. Storage and handling instructions must be followed to prevent contamination and maintain efficacy.
Frequently asked questions
What types of wear schedules are supported by the Fluorperm PAFLUFOCON A RGP contact lens, and how does the material contribute to extended wear comfort?
The Fluorperm PAFLUFOCON A RGP contact lens is specifically designed for extended wear, allowing for continuous overnight use under medical supervision. Its proprietary PAFLUFOCON A material enhances oxygen permeability, which supports prolonged contact with the eye while helping maintain corneal health. This design enables both single-use and multi-use protocols, depending on clinical guidance, ensuring comfort and stability during extended wear.
Is the Fluorperm PAFLUFOCON A RGP contact lens sterile at the point of sale, and what handling precautions must be taken before use?
No, the Fluorperm PAFLUFOCON A RGP contact lens is not sterile at the point of sale. It must be handled under aseptic conditions before use to prevent contamination. Proper storage and sterile techniques are critical to maintaining its safety and efficacy, as outlined in the manufacturer’s instructions.
How is the regulatory approval status of the Fluorperm PAFLUFOCON A RGP contact lens determined, and what does this mean for clinicians?
The Fluorperm PAFLUFOCON A RGP contact lens holds FDA Pre-Market Approval (PMA) under the designation P870024, with subsequent updates (e.g., S001, S011) addressing design modifications. This approval pathway ensures the device meets rigorous safety and performance standards for extended-wear contact lenses, as regulated under 21 CFR 886.5916. Clinicians can rely on this approval to confirm the lens’s compliance with FDA requirements for corneal reshaping and overnight wear.
Are there different sizes or models available for the Fluorperm PAFLUFOCON A RGP contact lens, and how are they determined?
While the provided data does not list specific sizes or models numerically, the Fluorperm PAFLUFOCON A RGP contact lens is professionally fitted by an eye care practitioner to ensure proper corneal reshaping and comfort. The exact size or model is determined based on the patient’s corneal curvature and prescription, following standard ophthalmic fitting protocols for RGP 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: CooperVision | Live Brightly.| Eye Contacts, FLUOROPERM RGP CONTACT LENSES PMA P870024S011 - FDA.report, FLUOROPERM RGP CONTACT LENSES PMA P870024S001 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P870024 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (1)
- FDA PMA P870024 24 fields · synced Sep 20, 2026