Micromed
LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the EEG recording. The patient’s retina is stimulated with bright light flashes in order to stimulate…
LED PHOTIC lamp is used in LED PHOTIC System for the stimulation of the patient during the EEG recording. The patient’s retina is stimulated with bright light flashes in order to stimulate brain activity changes. These changes can be used to evaluate brain functioning. The stimulation methods, like the photic stimulation, are integral part of the EEG exams.
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xian Friendship Medical Electronics Co., Ltd. | Xi’An | Shaanxi | Contract manufacturer | 10 |
Record
| Listed by | Micromed, Inc., United States |
|---|---|
| FDA product code | GWE |
| Device type | Stimulator, Photic, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1890 |
| 510(k) | K211974 |
| Record published | 2021-10-25 |
| Record revised | 2019-07-12 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LED PHOTIC | In distribution | |
| SystemPlus EVOLUTION | In distribution | |
| LED PHOTIC POWER | In distribution | |
| BRAIN QUICK SOFTWARE | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Espion | Diagnosys LLC | 129 |
| Utas | L K C Technologies, Inc. | 34 |
| Diopsys® | Diopsys Inc. | 13 |
| Stimulator, Photic, Evoked Response | Medtronic Xomed, Inc. | 6 |
| Natus | Xltek | 4 |
| Lifelines Photic Stimulator | Lifelines Ltd. | 2 |
| RETI-port/scan 21 gamma plus | Roland Consult Stasche & Finger GmbH | 2 |
| Sierra Summit | Cadwell Industries, Inc. | 2 |
| RETI-port/scan 21 delta plus | Roland Consult Stasche & Finger GmbH | 2 |
| Stimulator, Photic, Evoked Response | Medtronic Sofamor Danek, Inc. | 2 |
| RETI-port/scan 21 gamma | Roland Consult Stasche & Finger GmbH | 1 |
| Cascade Pro | Cadwell Industries, Inc. | 1 |
Showing 12 of 41. All products under Stimulator, Photic, Evoked Response
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.