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W-55 and Horizon 55 Soft Extended Wear Contact Lenses

by Westcon Contact Lens Co., Inc.

PMA P990072510(k) K954524

Active United States

PMA, withdrawn 510(k)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), FDA PMA, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA PMA PMA NumberP990072 Date22 Aug 2000ApprovedStatusWithdrawn
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK954524 Date28 Mar 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  • Withdrawn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), FDA PMA Active

Specification

510(k) · PMA

Full name
W-55 (Methafilcon a) and Horizon 55 Soft Extended Wear Contact Lenses
Generic Name
Lenses, soft contact, extended wear
PMA Number
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, 18 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 W-55 and Horizon 55 soft hydrophilic contact lenses are designed for the correction of visual acuity in non-aphakic persons with non-diseased eyes. These lenses are suitable for individuals who are myopic or hyperopic and may be worn by those with astigmatism of 1.50 diopters or less that does not interfere with visual acuity.

These devices are indicated for extended wear ranging from 1 to 7 days between removal for cleaning, rinsing, and disinfecting as recommended by an eye care practitioner. The lenses are available in both clear and visibility tint options. They are manufactured by Westcon Contact Lens Co., Inc. and have received FDA 510(k) and PMA authorizations.

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Questions

AI-generated answers, 18 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 recommended wear schedule for these lenses?

    These lenses are indicated for extended wear from 1 to 7 days, after which they must be removed for cleaning, rinsing, and disinfecting as directed by your eye care practitioner.

  • Can these lenses correct astigmatism?

    Yes, these lenses may be worn by persons who exhibit astigmatism of 1.50 diopters or less, provided that the astigmatism does not interfere with visual acuity.

  • Who is the intended patient for the W-55 and Horizon 55 lenses?

    These lenses are intended for non-aphakic persons with non-diseased eyes who require correction for myopia or hyperopia.