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Sign in to claim this brandLIGHTLAB IMAGING, INC.
US
Last updated May 24, 2026
What LIGHTLAB IMAGING, INC. makes
LightLab Imaging, Inc. manufactures intravascular imaging systems and catheters for coronary and peripheral vascular assessment, including optical coherence tomography (OCT) systems and pressure-measuring catheters. Their portfolio includes OCT catheters for detailed vessel wall imaging, guidewires for procedural guidance, and pressure-sensing catheters for functional flow reserve measurements. The company also produces standalone OCT imaging systems and hybrid systems combining OCT with intravascular ultrasound (IVUS).
The company’s devices are classified as Class II under FDA regulations and are authorised through 510(k) clearances and the Unique Device Identifier (UDI) system. These products are listed in the FDA’s regulatory databases, ensuring compliance with U.S. medical device standards. The manufacturer is based in the United States.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does LightLab Imaging, Inc. manufacture?
LightLab Imaging, Inc. specializes in intravascular imaging and pressure measurement devices. Their portfolio includes coronary optical coherence tomography (OCT) systems, OCT catheters for detailed vessel imaging, single-use cardiac and peripheral vascular guidewires, and catheter-tip transducers for measuring pressure within blood vessels. These devices are designed to support coronary and peripheral vascular assessments, such as functional flow reserve measurements and vessel wall analysis.
Where is LightLab Imaging, Inc. based, and how does that affect its regulatory standing?
LightLab Imaging, Inc. is headquartered in the United States. As a U.S.-based manufacturer, its devices are subject to FDA regulations, including classification under the agency’s risk-based system. Since their products fall under Class II, they require premarket notification (510(k)) clearance or other regulatory pathways to demonstrate safety and effectiveness before commercialization in the U.S. market.
Which regulatory registries or databases list LightLab Imaging, Inc.’s devices?
LightLab Imaging, Inc.’s devices are listed in the FDA’s regulatory databases, specifically through 510(k) clearances and the Unique Device Identifier (UDI) system. These registries ensure compliance with U.S. medical device standards and provide transparency on authorised products. The UDI system, in particular, helps track devices throughout their lifecycle, including post-market surveillance.
How are LightLab Imaging, Inc.’s devices classified under FDA regulations, and why does this matter?
LightLab Imaging, Inc.’s devices are classified as Class II under FDA regulations, indicating a moderate level of risk that requires special controls to ensure safety and effectiveness. This classification means the manufacturer must submit a 510(k) premarket submission to demonstrate that their device is substantially equivalent to a legally marketed predicate device. The classification helps streamline oversight while ensuring these intravascular imaging and pressure-measurement tools meet necessary standards for clinical use.
What kinds of devices does LightLab Imaging, Inc. offer that combine multiple technologies?
LightLab Imaging, Inc. produces hybrid systems that integrate optical coherence tomography (OCT) with intravascular ultrasound (IVUS), such as the ILUMIEN™ OPTIS™ to OPTIS™ system. These devices combine imaging modalities to provide complementary views of coronary and peripheral vessels, enhancing diagnostic accuracy. For example, OCT offers high-resolution cross-sectional images of vessel walls, while IVUS provides broader structural context, improving procedural guidance and decision-making.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- sjm.com
- —
- —
- [email protected]
- Phone
- +1(855)478-5833
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 018493531
Catalogue (43)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Dragonfly OpStar™ | 1014651 | FDA UDI | Class II | Active |
| PressureWire™ | C12059 | FDA UDI | Class II | Active |
| Dragonfly™ | Kit | FDA UDI | Class II | Active |
| Optis™ | Mobile System | FDA UDI | Class II | Active |
| Ilumien™ | D.1 Software | FDA UDI | Class II | Active |
| Optis™ | Mobile System | FDA UDI | Class II | Active |
| ILUMIEN™ OPTIS™ to OPTIS™ | UIMG901003 | FDA UDI | Class II | Active |
| Ultreon™ | 1015310 | FDA UDI | Class II | Active |
| Dragonfly™ | Duo Kit | FDA UDI | Class II | Active |
| Optis™ | C408663 | FDA UDI | Class II | Active |
| AptiVue™ | 1014666 | FDA UDI | Class II | Active |
| Ultiri™ | 1015082 | FDA UDI | Class II | Active |
| Ilumien™ | D.1.1 Software | FDA UDI | Class II | Active |
| Optis™ | Integrated System | FDA UDI | Class II | Active |
| C7-Xr™ | C.0.4 Software Upgrade | FDA UDI | Class II | Active |
| Dragonfly™ | Duo | FDA UDI | Class II | Active |
| C7 Dragonfly™ | 100-100-00 | FDA UDI | Class II | Active |
| Ilumien™ | 900-700-00 | FDA UDI | Class II | Active |
| AptiVue™ | 1015209 | FDA UDI | Class II | Active |
| Ilumien™ | C408650 | FDA UDI | Class II | Active |
| Dragonfly™ OPTIS™ | C408645 | FDA UDI | Class II | Active |
| Optis™ | Integrated System | FDA UDI | Class II | Active |
| PressureWire™ | C12359 | FDA UDI | Class II | Active |
| Ilumien™ | OPTIS™ E.2 Software | FDA UDI | Class II | Active |
| Ilumien™ | D.2 Software | FDA UDI | Class II | Active |
| Optis™ | Metallic Stent Optimization Software | FDA UDI | Class II | Active |
| Optis™ | Mobile System | FDA UDI | Class II | Active |
| Optis™ | C408653 | FDA UDI | Class II | Active |
| Optis™ | Mobile System | FDA UDI | Class II | Active |
| Dragonfly™ OPTIS™ | C408646 | FDA UDI | Class II | Active |
| Optis™ | Software Upgrade | FDA UDI | Class II | Active |
| PressureWire™ | C12009 | FDA UDI | Class II | Active |
| Optis™ | Integrated System E.2 Software | FDA UDI | Class II | Active |
| OPTIS Metallic Stent Optimization E.4 SW | K160878 | FDA 510(k) | Class II | Active |
| Ilumien Optis | K123369 | FDA 510(k) | Class II | Active |
| OPTIS Mobile System | K152120 | FDA 510(k) | Class II | Active |
| Optis Integrated System, Dragonfly Optis Imaging Catheter | K141769 | FDA 510(k) | Class II | Active |
| Ilumien Optis | K150878 | FDA 510(k) | Class II | Active |
| Ilumien Optis, Dragonfly Optis Imaging Catheter | K141453 | FDA 510(k) | Class II | Active |
| ILUMIEN, Drageonfly OPTIS Imaging Catheter | K150237 | FDA 510(k) | Class II | Active |
| OPTIS Integrated System Mobile Workstation | K151286 | FDA 510(k) | Class II | Active |
| C7 Xr Imaging System | K111201 | FDA 510(k) | Class II | Active |
| C7 Xr Imaging System With C7 Dragonfly Imaging Catheter And Disposable Accessories | K093857 | FDA 510(k) | Class II | Active |
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