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Alden Hp (Hioxifilcon B) Sphere & Toric Soft Contact Lenses

by Alden Optical Labs., Inc.

510(k) K042242

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

3 closed

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 · Special NumberK042242 Date15 Sep 2004ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0986-2018 FDA Class II initiated 3 Nov 2017
    • Terminated Z-0989-2018 FDA Class II initiated 3 Nov 2017
    • Terminated Z-0990-2018 FDA Class II initiated 3 Nov 2017

    Contact lenses lack sterility assurance.

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  • Withdrawn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

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