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Coburn Optical Ind., Inc.

United StatesFDA applicant, unverified

Devices
15

What Coburn Optical Ind., Inc. makes

Coburn Optical Industries manufactures diagnostic and surgical ophthalmic devices, including automated perimeters for visual field testing, a retinometer for measuring refractive error, and a range of vitrectomy and irrigation-aspiration systems for cataract and retinal surgery. Their portfolio also includes slit-lamp-mounted microscopes for corneal endothelial imaging, laser photocoagulation units for retinal treatments, and disposable microsurgical knives for precision ocular procedures. The company produces magnifying systems (e.g., MAGNILINK) for surgical visualization and devices like the EYE-VAC for ocular suction applications.

The company’s devices are regulated under the US FDA, with products classified as Class I (general controls) and Class II (special controls), requiring 510(k) premarket notifications or PMA submissions where applicable. These devices are listed in the FDA’s 510(k) and PMA registries, reflecting their authorised status for commercial distribution in the United States.

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

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  • Automated Perimeters Ref K803159

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

  • Retinometer Ref K781507

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

  • Magnilink System 402/5 Ref K892350

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

  • Irrigation & Aspiration/Vitrectomy Device Ref K862188

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

  • Magnilink System 209 Ref K892349

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

  • Di-Crown Ref K812441

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

  • Coburn I/A System Ref K853457

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

  • Disp. Microsurgical Knives Ref K821737

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

  • Biophtal Clinical Endothelial Microscope Ref K801659

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

  • Magnilink System 101 Ref K892347

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

  • Meditec (Rodenstock) Laser Photocoagul Ref K791659

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

  • Eye-Vac Ref K801231

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

  • Magnilink System 602 Ref K892351

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

  • Magnilink System 201 Ref K892348

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

  • Neodymium-Yag Op Laser Opl-3 Ref P830064

    Active Regimes: PMA Registry: PMA Class:II

Rows 1-15 of 15

Frequently asked questions

How many devices does Coburn Optical Ind., Inc. have in the registry?

The registry currently lists 15 devices for Coburn Optical Ind., Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Coburn Optical Ind., Inc.'s devices?

Among its 15 most recently registered devices, Coburn Optical Ind., Inc. has devices listed in FDA 510(k) (14 devices) and FDA PMA (1 device). A device can be listed in more than one registry, so these counts overlap.

What risk classes do Coburn Optical Ind., Inc.'s devices fall under?

Among its 15 most recently registered devices, the classes recorded for Coburn Optical Ind., Inc.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

What are the newest devices from Coburn Optical Ind., Inc. in the registry?

The most recently registered devices listed for Coburn Optical Ind., Inc. include AUTOMATED PERIMETERS, RETINOMETER, MAGNILINK SYSTEM 402/5 and IRRIGATION & ASPIRATION/VITRECTOMY DEVICE.

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