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MOLTENO3

by Iop, Inc.

510(k) K062252

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 NumberK062252 Date27 Sep 2006ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-1252-2016 FDA Class II initiated 22 Feb 2016

    Innovative Ophthalmic Products (IOP) is recalling the Molteno 3 G-Series Glaucoma Implant the package insert/Instructions for Use (IFU) for the device has been updated to add a caution statement to minimize off-label use.

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  • Withdrawn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
KYF
Device Class
Class II
Regulation
21 CFR Part 886.3920
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

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