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OptiMed Glaucoma Pressure Regulator

by Optimed, Inc.

510(k) K903462

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 NumberK903462 Date16 Oct 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  • Withdrawn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)

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, 1 Oct 2026

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

The OptiMed Glaucoma Pressure Regulator is an Eye Valve Implant (FDA classification: Class II, Product Code KYF) designed to reduce intraocular pressure in the anterior chamber of the eye. It is intended for use in patients with neovascular glaucoma or refractory glaucoma when conventional medical and surgical treatments have failed. Constructed from silicone tubing with a polymethyl methacrylate valve, the device functions as an aqueous shunt to manage fluid drainage and pressure regulation within the eye.

This device is supplied as a sterile, single-use implant and is regulated under FDA 510(k) clearance (K903462) with a decision of Substantially Equivalent (SESE). It is intended for ophthalmic surgical use and must be implanted by a qualified healthcare professional. The device adheres to FDA regulation 886.3920 and is distributed by Optimed, Inc. (Santa Barbara, CA). No MRI safety information is specified in the regulatory data.

Other devices from Optimed, Inc.

Questions

AI-generated answers, 1 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 is the OptiMed Glaucoma Pressure Regulator designed to treat?

    This device is intended for patients with neovascular glaucoma or refractory glaucoma when standard medical and surgical treatments have failed. It functions as an aqueous shunt to regulate intraocular pressure by managing fluid drainage in the anterior chamber of the eye.

  • How is the OptiMed Glaucoma Pressure Regulator supplied and prepared for use?

    The device is supplied sterile and as a single-use implant. It must be implanted by a qualified healthcare professional in an ophthalmic surgical setting, adhering to sterile technique protocols.

  • What materials are used in the construction of the OptiMed Glaucoma Pressure Regulator?

    The device is constructed from silicone tubing with a polymethyl methacrylate (PMMA) valve, designed to provide controlled aqueous drainage and pressure regulation within the eye.

  • Are there multiple sizes or models of the OptiMed Glaucoma Pressure Regulator?

    Yes, the device comes in multiple models, as indicated by the registration numbers (e.g., 3015217553, 3012341472, etc.), which may correspond to variations in size or design for different clinical needs.

  • What storage or handling instructions apply to the OptiMed Glaucoma Pressure Regulator?

    Since it is a sterile, single-use implant, the device should be stored in its original packaging under clean, dry conditions away from direct sunlight or extreme temperatures. Ensure the sterile barrier remains intact until immediate preoperative use.