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Collagen Implants for the Lacrimal Efficiency Test

by Lacrimedics, Inc.

510(k) K895342

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

This device is named in the recall

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 NumberK895342 Date2 Nov 1989ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0709-2022 FDA Class II initiated 17 Jan 2022

    The sterile pouch seal may contain channels that could affect the seal integrity and potentially compromise sterility.

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  • Withdrawn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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