Identifiers
- 510(k) Number
- K221471 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 E3 and Profile is a Photic Evoked Response Stimulator, designed to elicit and record visual evoked potentials (VEPs) in response to controlled light stimuli. It is classified under the regulatory category for evoked response photic stimulators, facilitating objective assessment of visual pathway function in clinical and research settings.
This system is supplied as a desktop visual electrophysiology unit paired with a mobile companion device, intended for use in neurology and ophthalmology clinics. Sterility is not applicable as it is a reusable medical device, though it must be cleaned and maintained per manufacturer guidelines. The device operates under FDA 510(k) clearance (K221471) and complies with the Medical Device Directive (MDD), regulated under 21 CFR 882.1890 as a Class II device with product code GWE.
Frequently asked questions
What clinical specialties primarily use the E3 and Profile system, and why is it relevant to them?
The E3 and Profile system is primarily used in neurology and ophthalmology clinics. It is designed to objectively assess visual pathway function by eliciting and recording visual evoked potentials (VEPs) in response to controlled light stimuli. This makes it relevant for diagnosing and monitoring conditions affecting the visual system, such as optic neuritis, retinal diseases, or neurological disorders impacting vision.
Is the E3 and Profile system reusable, and what maintenance is required to ensure proper function?
Yes, the E3 and Profile is a reusable medical device, meaning it is not single-use. To maintain its performance and ensure safety, it must be cleaned and maintained according to the manufacturer’s guidelines, as sterility is not applicable. Proper care is essential to preserve accuracy in eliciting and recording VEPs for clinical assessments.
How is the E3 and Profile system supplied, and what components does it include?
The E3 and Profile is supplied as a desktop visual electrophysiology unit paired with a mobile companion device. This setup allows for comprehensive testing of visual pathway function in clinical or research settings, combining a stationary main unit with a portable accessory for flexibility.
What regulatory pathways has the E3 and Profile system undergone, and what does this mean for its use?
The E3 and Profile has received FDA 510(k) clearance (K221471) under the Traditional pathway, with a decision of Substantially Equivalent (SESE) to a predicate device. It also complies with the Medical Device Directive (MDD) and is classified as a Class II device (product code GWE) under 21 CFR 882.1890. This means it has undergone rigorous review to ensure safety and effectiveness for use in clinical settings.
Are there multiple models or configurations of the E3 and Profile system, and how do they differ?
The data indicates multiple FEI numbers (Foreign Entity Identification numbers) associated with the E3 and Profile, suggesting variations in model configurations or regional adaptations for different markets. While the core functionality remains the same—eliciting VEPs—these differences may relate to regulatory compliance, software versions, or accessory compatibility. For exact specifications, refer to the manufacturer’s documentation or contact Diagnosys LLC.
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: K221471 FDA 510 (k) - E3 and Profile | Diagnosys, LLC, Diagnosys LLC Downloads - medical-xprt.com, PDF Diagnosys LLC Jeffrey Farmer CEO - Food and Drug Administration
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 | K221471 | Class II | Active |
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Manufacturer
- Manufacturer
- Diagnosys Llc
- FDA Applicant
- Diagnosys, LLC
Sources (2)
- FDA 510(k) K221471 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026