LED Daylite Reveal
The REVEAL FC is indicated for use as a wound autofluorescence imaging device to view autofluorescence images from skin wounds that are exposed to its excitation light.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Exact Medical Manufacturing, Inc. | Changzhou | Jiangsu | Contract manufacturer | 17 |
Record
| Listed by | Designs FOR Vision, Inc., United States |
|---|---|
| FDA product code | QCR |
| Device type | Wound Autofluorescence Imaging Device |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4165 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-06-24 |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Prescription | Prescription only |
| Label carries | expiry date, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9500-0000-0000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Ray 1 | Swift Medical | 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.