The following data is part of a premarket notification filed by Moleculight Inc. with the FDA for Moleculight I:x.
| Device ID | K191371 |
| 510k Number | K191371 |
| Device Name: | MolecuLight I:X |
| Classification | Autofluorescence Imaging Adjunct Tool For Wounds |
| Applicant | MolecuLight Inc. Suite 700, 425 University Avenue Toronto, CA M5g 1t6 |
| Contact | Anil Amlani |
| Correspondent | Joel Ironstone Ironstone Product Development Suite 222, 276 Carlaw Avenue Toronto, CA M4m 3l1 |
| Product Code | QJF |
| CFR Regulation Number | 878.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-22 |
| Decision Date | 2019-12-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00628110259325 | K191371 | 000 |