Skip to content

Amniolens

by Bio-Tissue, Inc.

510(k) K032104

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 9 Oct 2026. What this means

Regulatory status

as of registry sync 9 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK032104 Date12 Dec 2003ClearedStatusActive

Recalls

3 recalls · FDA

  • 3 recalls, same reason

    • Terminated Z-0550-2021 FDA Class II initiated 10 Nov 2020
    • Terminated Z-0551-2021 FDA Class II initiated 10 Nov 2020
    • Terminated Z-0552-2021 FDA Class II initiated 10 Nov 2020

    Potential exposure of product to microbial contamination.

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  • Withdrawn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
NQB
Device Class
Class II
Regulation
21 CFR Part 886.3130
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent