Skip to content

UltraCon/UltraCon S Rigid Gas Permeable Contact Lens for Daily Wear

by Specialty Ultravision, Inc.

510(k) K980197

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK980197 Date4 Aug 1998ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
HQD
Device Class
Class II
Regulation
21 CFR Part 886.5916
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The UltraCon/UltraCon S is a rigid gas permeable contact lens designed for daily wear. It falls under the category of 'Lens, Contact (Other Material) - Daily' and is intended for correcting refractive ametropia, including myopia, hyperopia, and astigmatism up to 4.00 diopters in non-aphakic individuals with non-diseased eyes. The lens features a hybrid design with spherical and aspherical curves, ensuring optimal fit and vision correction.

These lenses are supplied as single-use, non-sterile devices and are regulated under FDA 510K clearance (K980197) as substantially equivalent to existing products. They are intended for ophthalmic use only and must be handled and stored according to manufacturer guidelines. The UltraCon S variant is available in specific diameters and curvatures, as detailed in the product specifications. No MRI safety information is provided.

Other devices from Specialty Ultravision, Inc.

See all devices from Specialty Ultravision, Inc. →

Questions

AI-generated answers, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the UltraCon/UltraCon S rigid gas permeable contact lens intended for?

    The UltraCon/UltraCon S is intended for correcting refractive ametropia, including myopia, hyperopia, and astigmatism up to 4.00 diopters in non-aphakic individuals with non-diseased eyes. It is designed for daily wear and falls under the category of 'Lens, Contact (Other Material) - Daily'.

  • How is the UltraCon/UltraCon S contact lens supplied and is it sterile?

    The UltraCon/UltraCon S is supplied as a single-use, non-sterile device. It is not provided in a sterile condition and must be handled and stored according to manufacturer guidelines prior to use.

  • What regulatory pathway was used for the UltraCon/UltraCon S contact lens?

    The UltraCon/UltraCon S received FDA 510(k) clearance (K980197) as substantially equivalent to existing predicate devices. It is regulated under the traditional 510(k) pathway and classified as a Class II medical device.