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Modified Molteno Implants

by Iop, Inc.

510(k) K902489

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

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 NumberK902489 Date14 Aug 1990ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

Full name
Modified Molteno(Tm) Implants
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

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Modified Molteno Implants are ophthalmic devices classified as implantable eye valves. These devices are designed for use in ophthalmic procedures to manage glaucoma by facilitating aqueous humor drainage from the eye.

The Modified Molteno Implants are supplied as a single-use device and require appropriate storage conditions. The device received FDA 510(k) clearance with K number K902489 on August 14, 1990, and is classified under product code KYF as a class II medical device.

Other devices from Iop, Inc.

See all devices from Iop, Inc. →

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What are Modified Molteno Implants used for?

    Modified Molteno Implants are ophthalmic devices designed for use in procedures to manage glaucoma by facilitating aqueous humor drainage from the eye. They are classified as implantable eye valves.

  • How are Modified Molteno Implants supplied?

    The Modified Molteno Implants are supplied as a single-use device and require appropriate storage conditions. They are manufactured by Iop, Inc. and are designed for one-time use only.

  • What is the regulatory status of Modified Molteno Implants?

    The device received FDA 510(k) clearance with K number K902489 on August 14, 1990, and is classified under product code KYF as a class II medical device. It was determined to be substantially equivalent to predicate devices.

  • Are there different sizes or models of Modified Molteno Implants available?

    The device data does not specify different sizes or models of Modified Molteno Implants. The information provided indicates a single device type classified as an implantable eye valve for glaucoma management.