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Horizon/Westhin 55-G

by Westcon Contact Lens Co., Inc.

510(k) K962121

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 NumberK962121 Date26 Aug 1996ClearedStatusActive

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  • Withdrawn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
LPL
Device Class
Class II
Regulation
21 CFR Part 886.5925
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 22 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 Horizon/Westhin 55-G is a soft contact lens intended for daily wear. It functions as an ophthalmic device designed to correct vision.

This device is authorized under FDA 510(k) clearance K962121. It is manufactured by Westcon Contact Lens Co., Inc.

Other devices from Westcon Contact Lens Co., Inc.

See all devices from Westcon Contact Lens Co., Inc. →

Questions

AI-generated answers, 22 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 intended use of the Horizon/Westhin 55-G?

    The Horizon/Westhin 55-G is an ophthalmic device designed to function as a soft contact lens for the correction of vision.

  • What is the regulatory status of this device?

    This device is authorized under FDA 510(k) clearance K962121, which signifies it has been reviewed and cleared for market distribution.

  • What is the recommended wear schedule for these lenses?

    The Horizon/Westhin 55-G is specifically intended for daily wear, meaning the lenses should be removed at the end of each day as directed by an eye care professional.