Instruments for functional explorations and therapeutic interventionsOphthalmology instruments
Therapeutic and surgical ophtholmological treatments instruments
EMDN code Z121202
Manufacturers registered in Europe (EUDAMED) 20
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 98
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| OPHTHALMED LLC | United States | – | K142830 (2015) |
| Microsurgical Technology, Inc. | United States | MST/Packard A1 .7mm Phaco Tip Bent Dewey 30° MST .7mm A1 Bent Phaco Tip 45° MST/Packard A1 .7mm Phaco Tip Bent Dewey 45° MST/Packard A1 .7mm 12° Bend Phaco Tip, Reverse Bevel MST/Packard .7mm Bent Phaco Tip 30° MST/Packard A1 .7mm 12° Bend Phaco Tip Dewey 45° | K953959 (1995) |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb Stellaris Millennium MICS SIL I/A HDP 45° STELL 1/B SILICONE I/A HANDP CURVED 1/B IRR HANDPIECE SMOOTH,20G,12/BX | K261264 (2026) |
| Peregrine Surgical , Ltd. | United States | 27GA Curved Laser Probe - Iridex 27GA Curved Illuminating Laser Probe - Iridex 25GA Curved Illuminating Laser Probe - Short 27GA Curved Illuminating Laser Probe - DORC 25GA Curved Illuminating Laser Probe 27GA Curved Illuminating Laser Probe - Alcon | K132614 (2013) |
| KATALYST SURGICAL LLC | United States | 25ga Extendable MultiFlex Laser Probe, Dorc Connector 23ga Illuminated MultiFlex™ Laser Probe, Iridex Connector 25ga MultiFlex Laser Probe, Dorc Connector Laser Probe OS4, MultiFlex Extendable, 25ga Khaimi Concentrator, 0.15 mL 25ga Revolver Flexible Curved Illuminated | K140362 (2014) |
| FCI S A S FCI 20 22 | – | 90° ADJUSTABLE LASER PROBE, 23G NIDEK T.CURVED ILLUM LASER PROBE,25G QUANTEL & 19G NEEDLE STRAIGHT LASER PROBE, 20G DORC STRAIGHT LASER PROBE, 20G IRIDEX/B&L T.CURVED ILLUM LASER PROBE,23G QUANTEL & 19G NEEDLE 90° ADJUSTABLE LASER PROBE, 25G DORC | registered |
| Synergetics, Inc. | United States | Synergetics VersaVit | K113857 (2012) |
| SIE AG, Surgical Instrument Engineering | Switzerland | Procedure Pack FEMTO LDVᵀᴹ Intershields FEMTO LDV SIM-LASIK Pack Procedure Pack Z8 FEMTOLDV | K213559 (2022) |
| Medical Instrument Development Laboratories, Inc. | United States | Bi-Blade® Bi-Blade™ Adaptable Vit Enhancer™ Ultimate Vit Enhancer™ | K153168 (2016) |
| Oertli Instrumente AG Present in Europe in other categories | Switzerland | Oertli® | K233398 (2024) |
| Ellex Medical Pty, Ltd. Present in Europe in other categories | Australia | Ellex UltraQ Reflex Solo 2RT Integre Pro Scan Yellow Tango Neo | K222395 (2022) |
| Lightmed Corp. Present in Europe in other categories | Taiwan | TruScan Pro Lightlas SeLecTor Deux SYL-9000 YAG Laser LightLas 532 LightLas 577 LightLas 810 | K190448 (2019) |
| MICROSPECIALITIES, INC. | – | – | registered |
| Medical Technical Products | United States | US Handpiece, Standard Irrigation Sleeve, 20GA, Pack 5 Vinyl Cover, M3000 Aspiration Tip, .3mm, Straight Operators Manual, M3000 Operators Manual, M2000, Premium, Chinese | K940083 (1994) |
| Vortex Surgical, Inc. | United States | Vortex Surgical Inc Vortex Surgical Inc. 23ga Bending Laser Probe - Iridex Compatible 27ga Curved Laser Probe 25ga Bending Laser Probe - Alcon Compatible 23ga Straight Laser Probe | K220263 (2022) |
| Topcon Medical Laser Systems, Inc. | United States | PASCAL Synthesis PASCAL Laser Indirect Ophthalmoscope PACSAL Synthesis PASCAL Synthesis TwinStar | K180402 (2018) |
| Alma Lasers, Inc. Present in Europe in other categories | United States | FemiLift Sleeve FemiLift Slim Sleeve 24 iPixel Module - Line Scan With Wheel and Support FemiLift Handpiece Femilift HP & Camera Handpiece Focus 50mm for CO2 Alma | registered |
| This AG | Switzerland | SOPHI SOPHI A Phaco Set Sophi - 20G/Curved Cassette Peristaltic Sophi ECO Phaco Set Sophi - 20G/30° Phaco Set Sophi - 21G/30° | K250501 (2025) |
| MANI, INC. | – | MANI Infusion Cannula MANI Trocar MANI Trocar Kit | registered |
| AKTIVE SRL | Italy | Trocar set 20G with removable valve Trocar 23G with removable valve Trocar set 25G with removable valve Trocar set 27g with removable valve Trocar set 23G with removable valve Trocar 27G with removable valve | registered |
| Lensar, Inc. Present in Europe in other categories | United States | LENSAR LLS-fs 3D LLS/ALLY ALLY | K220259 (2022) |
| MICROVISION, INC. | United States | – | registered |
| Norlase ApS | Denmark | Norlase ECHO photocoagulator Norlase LION photocoagulator Norlase Leaf photocoagulator Norlase LYNX photocoagulator | K242397 (2024) |
| Optimedica Corporation | United States | LIQUID OPTICS INTERFACE CATALYS SYSTEM | K161455 (2016) |
| Technolas Perfect Vision GmbH Present in Europe in other categories | United States | ACCUGLIDE® Disposable Blade Zyoptix® XP Microkeratome Disposable Blades MICROKERATOME Disposable Tubing Patient Interface 125 Kit VICTUS™ Femtosecond Laser Platform | K200724 (2020) |
| Carl Zeiss Meditec Cataract Technology, Inc. | United States | MICOR Auto I/A MICOR extractor MICOR drive | K243395 (2025) |
| Lumenis Be, Ltd. Present in Europe in other categories | Israel | Selecta Duet™ Smart-V Illumination Add-on LaserLink S Digital Duet™ | K220877 (2022) |
| Meridian Medical d.o.o. Present in Europe in other categories | United Kingdom | MR Q Merilas MR Q supine MR Q SLT | registered |
| AMERICAN CONTRACT SYSTEMS, INC. | – | ACS | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Symmetry Surgical Symmetry Adson | registered |
| RUMEX INTERNATIONAL CORP. | United States | Rumex | registered |
| Belkin Vision, Ltd. | Israel | Eagle Voyager DSLT | K252979 (2026) |
| SIS AG, Surgical Instrument Systems | United States | AMADEUS | K043150 (2005) |
| Geuder Aktiengesellschaft | – | N.A. | registered |
| A.R.C Laser GmbH Present in Europe in other categories | United States | – | K170183 (2017) |
| A7 Precision Machine Technology Inc. | Canada | – | registered |
| AMC | United States | – | registered |
| ARMM INC. | United States | – | registered |
| AUROLAB | India | – | registered |
| AURORA SURGICAL, LLC | United States | – | registered |
| Abbott Medical Optics, Inc. | United States | – | K170322 (2017) |
| Alcon Research, Ltd. | United States | – | K191650 (2019) |
| Amo Manufacturng USA, LLC | United States | – | K200056 (2020) |
| Autocam Medical | United States | – | registered |
| B. Ali Impex | Pakistan | – | registered |
| Beaver-Visitec International, Inc. | United States | – | K240615 (2025) |
| Belle Healthcare Technology Co., Ltd. Present in Europe in other categories | China | – | registered |
| COASTLINE INTERNATIONAL, INC. | United States | – | registered |
| Can Technomed Trading LTD. | Canada | – | registered |
| Carl Zeiss Meditec Cataract Technologies | United States | – | K262097 (2026) |
| Celestica | Spain | – | registered |
| D.O.R.C. Dutch Ophthalmic Research Center (International) B. | Netherlands | – | registered |
| Elos Medtech Onyx | United States | – | registered |
| Eyeq, Inc. | United States | – | K243014 (2025) |
| Falcon Surgical Co. (Pvt.) Ltd. Present in Europe in other categories | Pakistan | – | registered |
| Flextronics International USA, Inc. | United States | – | registered |
| Garish Apparels | Pakistan | – | registered |
| HARMAC MEDICAL PRODUCTS, INC. | United States | – | registered |
| ISCON SURGICALS, LTD. | India | – | registered |
| JUNOPACIFIC INC. | United States | – | registered |
| Jabil Inc. | United States | – | registered |
| Lake Region Medical | United States | – | registered |
| Linemaster Switch Corp. | United States | – | registered |
| Lutronic Corporation Present in Europe in other categories | United States | – | K153769 (2016) |
| Lutronic Vision, Inc. Present in Europe in other categories | United States | – | K220974 (2022) |
| MANI, INC. (HEAD OFFICE) | Japan | – | registered |
| MEDONE SURGICAL, INC. | United States | – | registered |
| MEED SKILLS SURGICAL | Pakistan | – | registered |
| MOOG, INC. | United States | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Medicar Health Inc. | United States | – | registered |
| Meridian Co., Ltd. | Switzerland | – | K232417 (2024) |
| Micro Specialties, Inc. | United States | – | K033457 (2004) |
| Modo Inc | United States | – | registered |
| Omniguide, Inc. | United States | – | registered |
| OnCore Manufacturing LLC | United States | – | registered |
| PROVIDENCE ENTERPRISE LTD. | Hong Kong SAR China | – | registered |
| Precision Optics Corp. | United States | – | registered |
| Primo Medical Group, Inc | United States | – | registered |
| Psi/Eye-Ko, Inc. | United States | – | registered |
| QSA SURGICAL (PVT) LTD. | Pakistan | – | registered |
| Raico, LLC | United States | – | K192418 (2020) |
| Rg Medical USA | United States | – | registered |
| Roechling Medical Rochester, L.P. | United States | – | registered |
| SPARTECH INSTRUMENTS & CO. | Pakistan | – | registered |
| STERIMEDIX LTD. | United Kingdom | – | registered |
| STERIPAC GMBH | Germany | – | registered |
| Saint-Gobain Performance Plastics | United States | – | registered |
| Sanmina Corporation | United States | – | registered |
| Speedway Surgical Co. | India | – | registered |
| Strub Medical GmbH & Co. KG Present in Europe in other categories | Germany | – | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | – | registered |
| Univac Precision Engineering Pte Ltd | Singapore | – | registered |
| Viant Medical, LLC | United States | – | registered |
| Victor Medical Instruments Co., Ltd | China | – | registered |
| Visioncare Devices, Inc. | United States | – | K212763 (2022) |
| Vista Ophthalmics, LLC | United States | – | K220030 (2022) |
| ZIEMER OPHTHALMIC SYSTEMS AG | Switzerland | – | registered |
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