The following data is part of a premarket notification filed by Moleculight, Inc. with the FDA for Moleculight I:x.
| Device ID | K213840 |
| 510k Number | K213840 |
| Device Name: | MolecuLight I:X |
| Classification | Parathyroid Autofluorescence Imaging Device |
| 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 | QDG |
| CFR Regulation Number | 878.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-12-09 |
| Decision Date | 2022-05-18 |