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Collasyn Plug for the Lacrimal Efficiency Test

by Lacrimedics, Inc.

510(k) K140026

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 NumberK140026 Date3 Jun 2014ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1081-2015 FDA Class III initiated 26 Nov 2014

    Moisture level may cause the VisiPlugST (or CollaSyn Plugs) to break apart, or crumble upon contact. The firm's data also suggests that a 4 year shelf life may not be sustained.

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  • Withdrawn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
LZU
Device Class
U
Advisory Committee
Unknown
FDA Decision
SESE Substantially Equivalent

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