Diopsys Nova VEP Vision Testing System
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K101763 FDA 510(k)
- FDA Product Code
- GWE FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 882.1890 FDA 510(k)
- Regulation Number
- 882.1890 FDA 510(k)
- Advisory Committee
- Neurology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Diopsys Nova VEP Vision Testing System is a Photic, Evoked Response Stimulator designed to measure visual pathway function through electrophysiological testing. It objectively assesses the entire visual pathway, from the lens to the visual cortex, using Visual Evoked Potential (VEP) and pattern Electroretinography (ERG) techniques. This non-invasive device provides quantitative data to aid in the evaluation of ocular and neurological conditions affecting vision.
The system is intended for use in clinical settings, such as ophthalmology and neurology practices, where objective visual pathway assessment is required. Supplied as a reusable medical device, it adheres to FDA 510(k) and MDD regulatory standards. The system operates in non-sterile environments and is classified under device code GWE, with MRI safety considerations noted in its specifications. No single-use or sterile packaging details are provided in the regulatory data.
Frequently asked questions
What clinical conditions can the Diopsys Nova VEP Vision Testing System help evaluate using its objective testing methods?
The Diopsys Nova VEP Vision Testing System is designed to objectively assess the entire visual pathway, from the lens to the visual cortex, using Visual Evoked Potential (VEP) and pattern Electroretinography (ERG) techniques. This makes it particularly useful for evaluating ocular and neurological conditions that affect vision, such as optic neuritis, glaucoma, or other disorders impacting visual pathway function. The system provides quantitative data to aid clinicians in diagnosing and monitoring these conditions.
Is the Diopsys Nova VEP Vision Testing System intended for single-use or reusable applications, and what does this mean for maintenance?
The Diopsys Nova VEP Vision Testing System is classified as a reusable medical device. This means it is designed for repeated use in clinical settings, such as ophthalmology and neurology practices, and requires proper cleaning, disinfection, and maintenance procedures to ensure safety and reliability between uses. Since it operates in non-sterile environments, adherence to manufacturer guidelines for reprocessing is essential.
What regulatory pathways does the Diopsys Nova VEP Vision Testing System follow, and how does this affect its use in clinical settings?
The Diopsys Nova VEP Vision Testing System has been authorized through the FDA 510(k) pathway and complies with the Medical Device Directive (MDD) in the European market. This means it has been deemed substantially equivalent to a previously cleared device in the U.S. and meets the essential requirements for safety and performance under EU regulations. Clinicians can rely on its regulatory status to ensure it meets established standards for use in clinical settings like ophthalmology and neurology.
Does the Diopsys Nova VEP Vision Testing System have any special considerations for use in environments with MRI equipment?
Yes, the Diopsys Nova VEP Vision Testing System includes MRI safety considerations in its specifications. While the device itself is not sterile and is intended for non-sterile clinical environments, clinicians should follow the manufacturer’s guidelines regarding its compatibility with MRI environments to ensure safe and effective use. This is particularly important in settings where patients may require cross-referencing with MRI scans for comprehensive diagnostic evaluations.
What types of facilities or specialties would benefit most from integrating the Diopsys Nova VEP Vision Testing System into their workflow?
The Diopsys Nova VEP Vision Testing System is specifically intended for clinical settings such as ophthalmology and neurology practices. These specialties rely on objective assessments of visual pathway function to diagnose and monitor conditions like optic neuritis, neurological disorders affecting vision, or other pathologies impacting the visual system. Its non-invasive, quantitative testing approach makes it a valuable tool for clinicians seeking precise diagnostic data.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Diopsys USA - NOVA™ Vision Testing System, Diopsys VEP/pERG - CENTER FOR EYE-CARE EXCELLENCE, Diopsys® NOVA Vision Testing System | Enhance Eye Health Today - Book a ...
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K101763 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Diopsys, Inc.
Sources (2)
- FDA 510(k) K101763 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026