Identifiers
- 510(k) Number
- K043491 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 EnfantTM is a visual evoked potential (VEP) system designed for use in screening children. It is a photic stimulator that measures evoked responses to assess visual function in pediatric patients.
The device is supplied by Diopsys, Inc. and is intended for use in clinical settings. It has received FDA 510(k) clearance with the product code GWE and is classified as a Class II medical device. The system is designed to be child-friendly and can be used to test children aged 6 months to 5 years.
Frequently asked questions
What is the EnfantTM system used for?
The EnfantTM is a visual evoked potential (VEP) system designed for screening visual function in pediatric patients aged 6 months to 5 years. It measures evoked responses to assess visual function in clinical settings.
How is the EnfantTM system supplied?
The EnfantTM system is supplied by Diopsys, Inc. It is designed to be child-friendly and intended for use in clinical settings. The device is supplied as a complete system including the photic stimulator and necessary components for visual function assessment.
What is the regulatory status of the EnfantTM system?
The EnfantTM has received FDA 510(k) clearance with product code GWE and is classified as a Class II medical device. It was determined to be substantially equivalent through the traditional clearance process and reviewed by the Neurology advisory committee.
What age range is the EnfantTM system designed for?
The EnfantTM system is specifically designed for testing children aged 6 months to 5 years. Its child-friendly design makes it suitable for assessing visual function in this pediatric population.
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: PDF Submitter - Food and Drug Administration, 510(k) Premarket Notification - Food and Drug Administration
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K043491 | Class II | Active |
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Manufacturer
- Manufacturer
- Diopsys, Inc.
Sources (1)
- FDA 510(k) K043491 24 fields · synced Sep 24, 2026