Identifiers
- 510(k) Number
- K211974 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)
LED PHOTIC System is a stimulator, photic, evoked response device indicated for photic activation of the brain during electroencephalographic (EEG) studies. It is used to evaluate particular anomalies of brain activity by stimulating the patient's retina with bright light flashes to elicit brain activity changes.
The device must be used in combination with an EEG system. It is supplied as an accessory for EEG recording and is regulated as a Class 2 neurology device under product code GWE with FDA 510(k) clearance K211974. No information is provided regarding sterility, single-use or reusable status, MRI safety, sizes, or storage conditions.
Frequently asked questions
What is the LED PHOTIC System used for?
The LED PHOTIC System is indicated for photic activation of the brain during electroencephalographic (EEG) studies to evaluate particular anomalies of brain activity by stimulating the patient's retina with bright light flashes to elicit brain activity changes.
How is the LED PHOTIC System supplied and used?
The device is supplied as an accessory for EEG recording and must be used in combination with an EEG system to deliver photic stimulation during neurological assessments.
What regulatory pathway was used for the LED PHOTIC System?
The LED PHOTIC System received FDA 510(k) clearance under K211974 and is regulated as a Class 2 neurology device under product code GWE.
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: LED PHOTIC System by Micromed S.p.A. | FDA 510 (k) Summary, K211974 FDA 510 (k) - LED PHOTIC System | Micromed S.P.A., MICROMED SPA LED PHOTIC Micromed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K211974 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Micromed S.p.A.
Sources (1)
- FDA 510(k) K211974 24 fields · synced Oct 6, 2026