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Optical Micro Systems, Inc.

United StatesFDA applicant, unverified

Devices
21

What Optical Micro Systems, Inc. makes

Optical Micro Systems, Inc. manufactures surgical instruments and systems for ophthalmic procedures, including aspiration and infusion devices like the OMS Infusion-Aspiration Handle and Blood Pool & Subretinal Fluid Aspirator. The company also produces specialized tools such as the OMS/GonVers Retinal Perforator, OMS Anterior Chamber Infusion Needle, and Silicone Oil Injector, as well as cryotherapy tools (OMS Cryo) and scissors for precise ocular surgery. Additional products include the Aspiration Reversal Control (ARC) Module, Diplomax, and electric I/V poles for intraoperative fluid management.

The company’s portfolio spans FDA-regulated device classes, including Class I, Class II, and Class III products, with several cleared via the 510(k) pathway. These devices are listed under U.S. FDA regulatory records, and the manufacturer is based in the United States.

AI-generated from registry data, 3 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue21

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  • Aspiration Reversal Control (Arc) Module Ref K870068

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oms Infusion Cannula Assemble Ref K813481

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Diplomax Ref K946054

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oms Infusion-Aspiration Handle Ref K813500

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oms/Gonvers Retinal Perforator Ref K844448

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Ophthalmic Surgical System Ref K935223

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oms Anterior Chamber Infusion Needle Ref K813483

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Oms Silicone Oil Injector Ref K844895

    Active Regimes: 510(k) Registry: 510(k) Class:III

  • Blood Pool & Subvetinal Fluid Aspirator Ref K813274

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oms Scissors Ref K844510

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oms Cryo Ref K844467

    Active Regimes: 510(k) Registry: 510(k) Class:—

  • Electric I/V Pole Or EIVP2 Ref K935003

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Oms Slimline Phaco Handpiece Ref K950218

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Machemer/Tano Rotating Ref K833820

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Visc-X Vitreous Aspirating & Cutting Instrument Sy Ref K844715

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • I/V Pole Ref K935226

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • Oms Quartz Infusion Contact Lens Ref K820223

    Active Regimes: 510(k) Registry: 510(k) Class:I

  • O.M.S. Guillotine Cutter Ref K844374

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Hyposermic Needles Ref K813545

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Emergency Power Pac (Empac) Ref K813273

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • O.M.S. Ultra-Phaco Ref K844373

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-21 of 21

Frequently asked questions

How many devices does Optical Micro Systems, Inc. have in the registry?

The registry currently lists 21 devices for Optical Micro Systems, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Optical Micro Systems, Inc.'s devices?

Among its 21 most recently registered devices, Optical Micro Systems, Inc. has devices listed in FDA 510(k) (21 devices).

What risk classes do Optical Micro Systems, Inc.'s devices fall under?

Among its 21 most recently registered devices, the classes recorded for Optical Micro Systems, Inc.'s devices are Class I, Class II and Class III. Each device page shows its own class and authorisation.

What are the newest devices from Optical Micro Systems, Inc. in the registry?

The most recently registered devices listed for Optical Micro Systems, Inc. include ASPIRATION REVERSAL CONTROL (ARC) MODULE, OMS INFUSION CANNULA ASSEMBLE, DIPLOMAX and OMS INFUSION-ASPIRATION HANDLE.

Generated automatically from registry data and not verified by a human reviewer.