The Vision Monitor MonColor system is a photic stimulator that can perform pupillometry and dark adaptometry tests. ). It is intended to be used by a healthcare professional in a clinical…
The Vision Monitor MonColor system is a photic stimulator that can perform pupillometry and dark adaptometry tests. ). It is intended to be used by a healthcare professional in a clinical setting.
Who Else Makes It
Registered in Shaanxi. One is registered as a contract manufacturer, able to build to a specification.
Record
Regulatory record for Vision Monitor – MonColor | Listed by | Metrovision SAS, France |
| FDA product code | HLG |
| Device type | Pupillometer, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1700 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2026-07-01 |
Specifications
Specifications | MRI safety | Labeling does not contain MRI Safety Information |
| Label carries | manufacturing date, serial number |
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.