Instruments for functional explorations and therapeutic interventionsOphthalmology instrumentsTherapeutic and surgical ophtholmological treatments instruments
Therapeutic and surgical ophtholmological treatments instruments - consumables
EMDN code Z12120285
Manufacturers registered in Europe (EUDAMED) 4
- 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) 24
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 | – | registered |
| 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 | K113857 (2012) |
| 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) |
| 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 | registered |
| SIE AG, Surgical Instrument Engineering | Switzerland | Procedure Pack Z8 FEMTOLDV FEMTO | K213559 (2022) |
| Bausch & Lomb, Inc. Present in Europe in other categories | United States | Bausch + Lomb | registered |
| 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) |
| JOHNSON & JOHNSON SURGICAL VISION, INC. Present in Europe in other categories | United States | LIQUID OPTICS INTERFACE INTRALASE TECHNOLOGY PI CATALYS SYSTEM ELITA | K223566 (2023) |
| Lensar, Inc. Present in Europe in other categories | United States | LLS/ALLY LENSAR LLS-fs 3D ALLY | K220259 (2022) |
| Optimedica Corporation | United States | LIQUID OPTICS INTERFACE CATALYS SYSTEM | K161455 (2016) |
| D.O.R.C. Dutch Ophthalmic Research Center (International) B.V. Present in Europe in other categories | Netherlands | Illuminated Curved Laser probe, 25 gauge / 0,5mm with Alcon connector Illuminated Curved Laser probe, 25 gauge / 0,5mm with DORC® connector | registered |
| Technolas Perfect Vision GmbH Present in Europe in other categories | United States | Patient Interface 125 Kit VICTUS™ Femtosecond Laser Platform | K200724 (2020) |
| Abbott Medical Optics, Inc. | United States | – | K170322 (2017) |
| Amo Manufacturng USA, LLC | United States | – | K200056 (2020) |
| Flextronics International USA, Inc. | United States | – | registered |
| HARMAC MEDICAL PRODUCTS, INC. | United States | – | registered |
| JUNOPACIFIC INC. | United States | – | registered |
| Medical Wholsale Suplies, Inc, | Canada | – | registered |
| Nidek, Inc. Present in Europe in other categories | United States | – | K111493 (2011) |
| Primo Medical Group, Inc | United States | – | registered |
| Tecan U.S., Ltd. Present in Europe in other categories | United States | – | registered |
| Viant Medical, LLC | United States | – | registered |
| ZIEMER OPHTHALMIC SYSTEMS AG | Switzerland | – | registered |
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