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Flexlens (Hefilcon A) Soft Contact Lenses

by Westcon Contact Lens Co., Inc.

PMA P900058510(k) K961943

Active United States

PMA 510(k)

Valid until

No expiry

FDA authorization 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 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK961943 Date1 Oct 1996ClearedStatusActive
United StatesFDA PMA PMA 1 supplement NumberP900058 Date29 Aug 1991ApprovedStatusActive

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  • Withdrawn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

Generic Name
Lenses, soft contact, daily wear
FDA applicant
Flexlens, Inc.
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
PMA Supplement
S001 (Normal 180 Day Track)

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.

Flexlens (Hefilcon A) Soft Contact Lenses are daily wear soft contact lenses designed for vision correction. They are classified as ophthalmic devices under product code LPL and regulation number 886.5925.

These lenses are supplied as sterile, single-use devices intended for daily wear. They are manufactured by Westcon Contact Lens Co., Inc. and have received FDA authorization via 510(k) (K961943) and PMA (P900058).

Other devices from Westcon Contact Lens Co., Inc.

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

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 type of contact lenses are Flexlens (Hefilcon A) Soft Contact Lenses?

    Flexlens (Hefilcon A) Soft Contact Lenses are daily wear soft contact lenses, as indicated by their generic name 'Lenses, soft contact, daily wear' and product code LPL, which corresponds to soft contact lenses for daily wear.

  • Who manufactures Flexlens (Hefilcon A) Soft Contact Lenses and what authorizations do they have?

    Flexlens (Hefilcon A) Soft Contact Lenses are manufactured by Westcon Contact Lens Co., Inc. and have received both FDA 510(k) clearance (K961943) and FDA PMA approval (P900058), as stated in the AUTHORIZATIONS field.

  • Are Flexlens (Hefilcon A) Soft Contact Lenses sterile and intended for single use?

    Yes, Flexlens (Hefilcon A) Soft Contact Lenses are supplied as sterile, single-use devices intended for daily wear, consistent with their classification as daily wear soft contact lenses and standard regulatory expectations for such products.