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Vmate Model VMM1000

by Howard Instruments, Inc. 510(k)

Active United States

510(k) K030948

Overview

The VMate Model VMM1000 is an ac-powered vitreous aspiration and cutting instrument (Product Code HQE) designed for ophthalmic surgical procedures. It combines aspiration and cutting functions to remove vitreous humor, cellular debris, and other intraocular materials during vitrectomy or related interventions, aiding in the restoration of visual function and retinal stability.

This device is intended for single-use in controlled surgical environments, such as operating rooms, and is classified as Class II under 21 CFR 886.4150. It requires sterile packaging and must be handled in accordance with standard ophthalmic surgical protocols. The VMate Model VMM1000 holds an FDA 510(k) clearance (K030948) for substantial equivalence to predicate devices, ensuring compliance with regulatory standards for vitreous management instruments.

AI-generated from registry data, 19 Sep 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK030948 Date17 Jun 2003ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
HQE
Device Class
Class II
Regulation
21 CFR Part 886.4150
Advisory Committee
Ophthalmic
FDA Decision
SESE Substantially Equivalent

Other devices from Howard Instruments, Inc.

Questions

  • What types of ophthalmic surgeries is the VMate Model VMM1000 specifically designed to assist with?

    The VMate Model VMM1000 is designed for vitreous aspiration and cutting during vitrectomy procedures and related interventions. It helps remove vitreous humor, cellular debris, and other intraocular materials to restore visual function and stabilize the retina, which are critical steps in surgeries like posterior vitrectomy or other vitreoretinal procedures.

  • Is the VMate Model VMM1000 intended for reuse, or is it meant to be used only once?

    The VMate Model VMM1000 is explicitly intended for single-use in controlled surgical environments, such as operating rooms. This design ensures patient safety and sterility, aligning with standard ophthalmic surgical protocols.

  • How is the VMate Model VMM1000 packaged, and what sterility guarantees are provided?

    The VMate Model VMM1000 comes in sterile packaging, which is essential for maintaining surgical cleanliness. The manufacturer ensures it meets regulatory standards for sterility, making it ready for immediate use in sterile operating room conditions without additional sterilization.

  • What power source does the VMate Model VMM1000 use, and does this affect its portability or setup requirements?

    The VMate Model VMM1000 is ac-powered, meaning it requires access to an electrical outlet during use. This design may require additional setup, such as wiring or a nearby power source, but it ensures consistent performance without battery limitations.

  • How can I verify the regulatory compliance of the VMate Model VMM1000 before purchasing?

    The VMate Model VMM1000 holds an FDA 510(k) clearance (K030948), confirming its substantial equivalence to predicate devices under 21 CFR 886.4150. This clearance ensures it meets U.S. regulatory standards for vitreous aspiration and cutting instruments. For full details, you can reference the FDA’s openFDA database using the registration number 1932180 or the product code HQE.