CooperVision 38 (Polymacon) Hydrophilic Contact Lens
FDA PMAFDA 510(k)Class II (US FDA PMA)
Identity
- Trade Name
- COOPER(TM) 38 (POLYMACON) HYDROPHILIC CONTACT LENS FDA PMA
- Generic Name
- Lenses, soft contact, daily wear FDA PMA
Classification
- Device Class
- Class II FDA PMA
- Legislation / Framework
- 21 CFR Part 886.5925 FDA PMA
- Regulation Number
- 886.5925 FDA PMA
- Advisory Committee
- Ophthalmic FDA PMA
- FDA Decision
- SESE Substantially Equivalent FDA PMA
- PMA Supplement
- S001 FDA PMA
This device is a Lens, Soft Contact, Daily Wear, designed for corneal refractive correction. The Polymacon material provides a hydrophilic surface for comfortable, extended wear while maintaining optical clarity for vision correction.
The lens is intended for single-use or daily wear in ophthalmic settings and is supplied sterile. It is classified as Class II under FDA regulations, with FDA 510K and PMA authorisations (PMA Number: P810057). Available in various sizes and dioptric powers, storage requires adherence to manufacturer guidelines to preserve sterility and performance.
Frequently asked questions
What is the primary purpose of the COOPER™ 38 (POLYMACON) Hydrophilic Contact Lens, and how does its material contribute to its function?
The COOPER™ 38 (POLYMACON) Hydrophilic Contact Lens is designed for **corneal refractive correction**, meaning it is used to improve vision by reshaping the cornea. The **Polymacon material** provides a hydrophilic (water-attracting) surface, which enhances comfort during extended wear while maintaining optical clarity for clear vision. This makes it suitable for daily or single-use applications in ophthalmic settings.
Is this contact lens intended for single-use or reusable applications, and how should it be stored to maintain sterility?
The COOPER™ 38 (POLYMACON) Hydrophilic Contact Lens is **intended for single-use or daily wear**, meaning it is not designed for reuse. To preserve sterility and performance, storage must follow the manufacturer’s guidelines, which likely include keeping it in a sealed, sterile packaging until use and avoiding contamination.
What regulatory pathways have been followed for this device, and what does that mean for its use in clinical settings?
This device has undergone **FDA 510K and PMA (Premarket Approval) authorizations**, including PMA Number **P810057**, and is classified as **Class II** under FDA regulations. This means it has been evaluated for safety and effectiveness through formal regulatory processes, ensuring it meets established standards for use in clinical settings as a **Lens, Soft Contact, Daily Wear**.
Are there multiple sizes or dioptric powers available for this contact lens, and how would a clinician determine the appropriate fit?
Yes, the COOPER™ 38 (POLYMACON) Hydrophilic Contact Lens is available in **various sizes and dioptric powers**, as indicated by the multiple **FEI numbers** listed in the regulatory records. A clinician would determine the correct fit based on the patient’s prescription, corneal curvature, and refractive error, ensuring optimal vision correction and comfort.
How is the lens supplied, and what should a clinician or user know about its sterility before use?
The COOPER™ 38 (POLYMACON) Hydrophilic Contact Lens is **supplied sterile**, meaning it is packaged in a way that maintains its cleanliness until the moment of use. Clinicians or users should ensure the packaging remains unopened and intact before handling, as any breach could compromise sterility. Always follow the manufacturer’s instructions for opening and handling to prevent contamination.
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
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K001089 | Class II | Active |
| FDA PMA | United States | FDA_PMA | P810057 | Class II | Active |
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Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (2)
- FDA PMA P810057 36 fields · synced Sep 18, 2026
- FDA 510(k) K001089 1 fields · synced May 18, 2026