DEN180008 is an FDA 510(k) submission for the MolecuLight i:X. This device is classified as a Wound Autofluorescence Imaging Device (Class I - General Controls, product code QCR).
Submitted by Moleculight, Inc. (Toronto, CA). The FDA issued a Not Cleared (DENG) decision on July 31, 2018.
This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4165. A Wound Autofluorescence Imaging Device Is A Tool To View Autofluorescence Images From Skin Wounds That Are Exposed To An Excitation Light. The Device Is Not Intended To Provide Quantitative Or Diagnostic Information..
| 510(k) Number | DEN180008 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | February 16, 2018 |
| Decision Date | July 31, 2018 |
| Days to Decision | 165 days |
| Submission Type | Direct |
| Review Panel | General & Plastic Surgery (SU) |
| Summary | - |
| Product Code | QCR - Wound Autofluorescence Imaging Device |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 878.4165 |
| Definition | A Wound Autofluorescence Imaging Device Is A Tool To View Autofluorescence Images From Skin Wounds That Are Exposed To An Excitation Light. The Device Is Not Intended To Provide Quantitative Or Diagnostic Information. |