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Ciba Vision (Lotrafilcon B) Spherical, Toric, Multifocal and Toric Multifocal Designs

by Ciba Vision Corporation

510(k) K033919

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 · Traditional NumberK033919 Date12 Mar 2004ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0427-2007 FDA Unclassified (pre-2012) initiated 11 Jan 2007 on shared 510(k) K033919

    Reduced Ion Permeability

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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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