Preference (Tetrafilcon A) Soft (Hydrophillic) Contact Lenses
FDA PMAFDA 510(k)Class III (US FDA PMA)
Identity
- Trade Name
- AQUASEPT II FDA PMA
- Generic Name
- Lenses, soft contact, extended 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
- S010 FDA PMA
Preference is a soft contact lens made from tetrafilcon A, a hydrophilic material. It is classified as a soft contact lens intended for extended wear. The lens provides vision correction through its flexible, water-loving polymer structure.
These lenses are supplied by CooperVision and are regulated under FDA classifications for soft contact lenses. They are intended for use as extended wear lenses, meaning they can be worn continuously for multiple days. The device is subject to FDA 510(k) and PMA authorizations, with a Special clearance type and Ophthalmic advisory committee review.
Frequently asked questions
What material is the Preference contact lens made from?
The Preference contact lens is made from tetrafilcon A, which is a hydrophilic (water-attracting) polymer. This material is specifically designed for soft contact lenses and supports extended wear by maintaining hydration and oxygen permeability.
Is the Preference lens designed for daily or extended wear?
The Preference lens is classified under the generic category of soft contact lenses for extended wear. This means it is designed to be worn continuously for multiple days without removal, though specific wearing schedules should be determined by an eye care professional.
Who manufactures the Preference contact lens?
The Preference contact lens is manufactured by CooperVision, Inc., a company based in Scottsville, NY, with additional corporate offices in Pleasanton, CA. CooperVision is a recognized manufacturer of contact lenses and related ophthalmic devices.
What regulatory authorizations does the Preference lens have?
The Preference lens has received both FDA 510(k) and FDA PMA (Premarket Approval) authorizations. It was cleared under a Special clearance type with a Substantially Equivalent decision, reviewed by the Ophthalmic (OP) advisory committee. The K-number for this submission is K990606.
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: [PDF] Pro Vision Premium (methafilcon A), [PDF] K980649 - accessdata.fda.gov, Preference (tetrafilcon A) Soft (hydrophillic) Contact Lenses PMA ..., List of soft contact lens materials - Wikipedia, Biofinity Comfilcon A Lens Guide | PDF - Scribd
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_510K
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K950968 | Class III | Active |
| FDA 510(k) | United States | FDA_510K | K990606 | Class III | Active |
| FDA PMA | United States | FDA_PMA | N17679 | Class III | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Coopervision Inc.
- FDA Applicant
- CooperVision, Inc.
Sources (2)
- FDA PMA N17679 37 fields · synced Sep 18, 2026
- FDA 510(k) K950968 1 fields · synced May 18, 2026