Data / Medical devices / Canada / Moleculight Inc.
Moleculight Inc.: FDA-registered device maker in TORONTO Ontario, Canada, 2 510(k) clearances
Moleculight Inc. is registered with the FDA (registration 3014704068) in TORONTO Ontario, Canada. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated May 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014704068
- Address
- 425 University Ave, TORONTO Ontario, Canada, M5G1T6
- Owner or operator
- MolecuLight Inc. (10058911)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 11, 2019
- Registered through
- 2026
- Brand names listed
- MolecuLight DarkDrape, MolecuLight i:X, MolecuLightDX, MolecuLightDX DarkDrape, MolecuLightDX DarkDrape Eco, MolecuLightDX DarkDrape Eco Clip, MolecuLightDX Sterile Sleeve, MolecuLightDX+ and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Autofluorescence Imaging Adjunct Tool For Wounds | QJF | 2 | Manufacturer | accessdata.fda.gov |
| Drape, Surgical, Exempt | PUI | 2 | Manufacturer | accessdata.fda.gov |
| General Surgery Tray | LRO | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Tape, Camera, Surgical | FXN | 1 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| May 18, 2022 | K213840 | MolecuLight I:X | QJF | Substantially Equivalent | MolecuLight, Inc. | accessdata.fda.gov |
| July 21, 2021 | K211901 | MolecuLightDX | QJF | Substantially Equivalent | MolecuLight, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Autofluorescence Imaging Adjunct Tool For Wounds
- All makers of Tape, Camera, Surgical
- All makers of General Surgery Tray
- All makers of Drape, Surgical, Exempt
Updated May 18, 2022. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.