Lifelines Photic Stimulator
Lifelines Photic Stimulator generates brief flashes of white light for photic activation during EEG studies and generation of visual evoked potentials. A host computer controls the flashes,…
Lifelines Photic Stimulator generates brief flashes of white light for photic activation during EEG studies and generation of visual evoked potentials. A host computer controls the flashes, typically at repetition rates from 1 to 60 Hz.
The light source is a single high-intensity LED with associated optics. It is mounted on an adjustable support arm for positioning during the examination.
Control Interfaces
The device supports repeated stimulation or a single manually requested flash. Compatible host systems communicate through USB, TTL or serial control signals. The stimulator supplies a controlled visual stimulus while the separate neurophysiology system records the response.
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 | Lifelines Ltd., United Kingdom |
|---|---|
| FDA product code | GWE |
| Device type | Stimulator, Photic, Evoked Response |
| Device class | Class 2 |
| Regulation | 21 CFR 882.1890 |
| Establishment | Specification developer, Manufacturer |
| 510(k) | K101691 |
| Record published | 2019-07-04 |
| Record revised | 2025-10-15 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Photic Stimulator | In distribution | |
| Photic Stimulator Kit | 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 |
| Micromed | Micromed, Inc. | 4 |
| 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K101691 | 2010-08-10 |
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.