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Sign in to claim this brandLKC Technologies
United States·US-MF-000030631
Last updated September 18, 2026
About
Industry leaders in Electroretinography (ERG) and visual evoked potential (VEP): Achieve superior patient outcomes and power your research with ERG/VEP testing for an objective, more complete understanding of retinal function.
From the manufacturer's own website. Source
What LKC Technologies makes
LKC Technologies manufactures electroretinography (ERG) systems and associated electrodes, including diagnostic devices like the RETeval™ and UTAS platforms. These tools measure retinal function through electrical responses, supporting clinical assessments and research. The company also produces disposable sensor strip electrodes for ERG testing, packaged in bulk sets of 25.
The company’s devices are classified under FDA regulations as Class I, Class II, and Class IIa, with listings in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system. 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 LKC Technologies manufacture?
LKC Technologies specializes in electroretinography (ERG) devices, which measure the electrical responses of the retina to light stimuli. Their product line includes ERG systems like the RETeval™ and UTAS platforms, as well as disposable sensor strip electrodes (sold in bulk boxes of 25). These tools are primarily used in clinical diagnostics and research to assess retinal function objectively.
Where is LKC Technologies based, and what regulatory databases list their devices?
LKC Technologies is headquartered in the United States. Their devices are listed in the EU’s eudamed database and the FDA’s Unique Device Identifier (UDI) system, ensuring traceability and compliance with international regulatory requirements.
How are LKC Technologies’ devices classified under FDA regulations?
LKC Technologies’ devices fall under Class I, Class II, and Class IIa classifications according to FDA regulations. Class I devices pose minimal risk and typically require general controls, while Class II and IIa devices involve more stringent regulatory oversight due to moderate or higher risk levels, such as those associated with diagnostic accuracy or patient safety.
What is the primary purpose of LKC Technologies’ ERG systems and electrodes?
LKC Technologies’ ERG systems (e.g., RETeval™ and UTAS) and disposable electrodes are designed to evaluate retinal function by recording electrical responses to light. These devices support clinical diagnoses of retinal diseases, monitor patient progress, and enable research into vision-related conditions by providing objective, quantitative data.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 20501 Seneca Meadows Parkway , Germantown , United States
- Website
- www.lkc.com
- facebook.com/LKCTech
- [email protected]
- Phone
- +1 301 840 1992
- PRRC Contact
- Ed Crown
- EUDAMED SRN
- US-MF-000030631
- FDA FEI Number
- —
- DUNS Number
- —
Catalogue (63)
Page 2 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| RETeval Complete | 00857901006040 | EUDAMEDFDA UDI | Class IIa | Active |
| Universal Testing & Analysis Systems | K820414 | FDA 510(k) | Class II | Active |
| RETeval Visual Electrodiagnostic Device | K142567 | FDA 510(k) | Class II | Active |
| Pattern Discrimination Perimeter | K874336 | FDA 510(k) | Class I | Active |
| Anomaloscope Plate Test - 5 [apt-5] | K875026 | FDA 510(k) | Class I | Active |
| Electroretinograph | K760199 | FDA 510(k) | Class II | Active |
| Scoptopic Sensitivity Test-1[sst-1] | K914163 | FDA 510(k) | Class II | Active |
| Telemetry, Biomedical | K790109 | FDA 510(k) | Class II | Active |
| Anomaloscope Quadrant Test-6 | K913962 | FDA 510(k) | Class I | Active |
| RETeval Flicker | 00857901006484 | EUDAMED | Class IIa | Active |
| Sensor Strip Electrodes (Box of 50) | 95-068 | EUDAMEDFDA UDI | Class I | Active |
| Small Sensor Strip Electrodes (Box of 50) | 95-090 | EUDAMEDFDA UDI | Class I | Active |
| UTAS Pattern/Multifocal System | 00857901006583 | EUDAMEDFDA UDI | Class IIa | Active |
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