The following data is part of a De Novo classification by Moleculight Inc. with the FDA for Moleculight I:x.
| DeNovo ID | DEN180008 |
| Device Name: | MolecuLight I:X |
| Classification | Wound Autofluorescence Imaging Device |
| Applicant | MolecuLight Inc. 101 College St. Suite 200 Toronto, CA M5g 1l7 |
| Contact | Jeffrey K. Shapiro |
| Product Code | QCR |
| CFR Regulation Number | 878.4165 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(de Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | General & Plastic Surgery |
| Classification Advisory | General & Plastic Surgery |
| Type | Direct |
| Date Received | 2018-02-16 |
| Decision Date | 2018-07-31 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |