The following data is part of a premarket notification filed by Moleculight Inc. with the FDA for Moleculightdx.
| Device ID | K211901 |
| 510k Number | K211901 |
| Device Name: | MolecuLightDX |
| Classification | Autofluorescence Imaging Adjunct Tool For Wounds |
| Applicant | MolecuLight Inc. Suite 700, 425 University Avenue Toronto, CA M5g 1t6 |
| Contact | Jordan John |
| Correspondent | Jordan John MolecuLight Inc. Suite 700, 425 University Avenue Toronto, CA M5g 1t6 |
| Product Code | QJF |
| CFR Regulation Number | 878.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-06-21 |
| Decision Date | 2021-07-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628110259387 | K211901 | 000 |