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SUS (Stenfilcon A) Contact Lens

FDA 510(k)

Class II (US FDA 510(k))

510(k) K131378

by Coopervision Inc.

Identifiers

510(k) Number
K131378 FDA 510(k)
FDA Product Code
LPL FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.5925 FDA 510(k)
Regulation Number
886.5925 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The SUS (Stenfilcon A) Contact Lens is a Soft Contact Lens, Daily Wear (product code LPL), designed for vision correction. It is classified as a silicone hydrogel lens with a water content of 54% and a material composition of 46% stenfilcon A. This device is intended for single-use, providing clear and comfortable vision correction for daily wear applications.

The lens is supplied sterile in buffered saline and features a blue visibility tint (Reactive Blue #246) and a UV blocker. Available in aspherical, toric, multifocal, and multifocal toric designs, it is intended for ophthalmic use. The device holds FDA 510(k) clearance (K131378) under the regulatory classification of Class II – Special Controls, with a decision date of August 30, 2013.

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: K131378 FDA 510 (k) - SUS (STENFILCON A) CONTACT LENS, SUS (STENFILCON A) CONTACT LENS (K131378) - Innolitics, PDF K131378 - Sus (Stenfilcon A) Contact Lens

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Coopervision Inc.
FDA Applicant
CooperVision, Inc.

Sources (1)

  • FDA 510(k) K131378 24 fields · synced Sep 19, 2026