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Solo-Care Plus Multipurpose Solution

by Ciba Vision Corporation 2 variants

510(k) K031522

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 NumberK031522 Date27 Jun 2003ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0028-05 FDA Unclassified (pre-2012) initiated 27 Sep 2004

    Stability tests at 24 months revealed failing results for disinfection efficacy.

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  • Withdrawn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
LPN
Device Class
Class II
Regulation
21 CFR Part 886.5928
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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