MolecuLight I: X System
MolecuLight i:X is a handheld imaging device for clinicians examining skin wounds at the point of care. It records standard wound photographs, measures wound area and captures fluorescence…
MolecuLight i:X is a handheld imaging device for clinicians examining skin wounds at the point of care. It records standard wound photographs, measures wound area and captures fluorescence images of the wound and surrounding skin.
Light emitting diodes illuminate the tissue, and an optical camera detects the resulting fluorescence. Fluorescent molecules absorb the excitation light and emit light at longer wavelengths, creating an image that the clinician views on the integrated color touchscreen.
Listed Item
The MolecuLight i:X is a handheld imaging tool that allows clinicians diagnosing and treating skin wounds, at the point of care, to: (i) View and digitally record images of a wound, (ii) Measure and digitally record the size of a wound, and (iii) View and digitally record images of fluorescence emitted from a wound when exposed to an excitation light. The fluorescence image, when used in combination with clinical signs and symptoms, has been shown to increase the likelihood that clinicians can identify wounds containing bacterial loads >10^4 CFU per grams as compared to examination of clinical signs and symptoms alone. The MolecuLight i:X device should not be used to rule-out the presence of bacteria in a wound.
Interpreting Fluorescence
Fluorescence images must be interpreted alongside clinical signs and symptoms and, where needed, confirmatory methods such as bacterial culture. The fluorescence output does not establish bacterial load by itself, and the device cannot rule out bacteria in a wound.
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 | Moleculight Inc., Canada |
|---|---|
| FDA product code | QJF |
| Device type | Autofluorescence Imaging Adjunct Tool For Wounds |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4550 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| 510(k) | K191371 |
| Record published | 2022-01-04 |
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 |
|---|---|---|
| 1153-11 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MolecuLightDX System | Moleculight Inc. | 2 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213840 | 2022-05-18 |
| K211901 | 2021-07-21 |
| K210882 | 2021-06-22 |
| K191371 | 2019-12-04 |
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.