NL-2
NeuroLight kit (NeuroLight portable pupillometer NL-MU, wireless charging station STA-W2, 10 eyecups EMB-NL, power supply PWR5-1_US, and user manual)
1manufacturer
1catalogue number
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 |
|---|---|---|---|---|
| Taiyuan North China Xinyuan Tech. Center (Co., Ltd.) | Taiyuan | Shaanxi | Contract manufacturer | 14 |
Record
| Listed by | Idmed Corp., United States |
|---|---|
| FDA product code | HLG |
| Device type | Pupillometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1700 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-01-24 |
| Record revised | 2022-06-13 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| NL-2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| RETeval™ | L K C Technologies, Inc. | 12 |
| NeurOptics | Neuroptics, Inc. | 10 |
| STA-W2 | Idmed Corp. | 1 |
| Vissard 3D, linear polarized | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| NL-2-DEM | Idmed Corp. | 1 |
| Zeiss Mobile Centration | Carl Zeiss Vision Gmbh | 1 |
| NL-MU | Idmed Corp. | 1 |
| Digital C.R.P | Essilor International | 1 |
| Vissard 3D, circular polarized | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| Vissard RG | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| PD Meter | Nidek Incorporated | 1 |
| Vision Monitor – MonColor | Metrovision SAS | 1 |
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.