Data / Medical devices / Canada / Toefx Inc.
Toefx Inc.: FDA-registered device maker in Hamilton Ontario, Canada, 1 510(k) clearance
Toefx Inc. is registered with the FDA (registration 3030926983) in Hamilton Ontario, Canada. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated November 17, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030926983
- Address
- 175 Longwood Road, Unit 111A-B, Hamilton Ontario, Canada, L8P 0A1
- Owner or operator
- ToeFx Inc. (10090589)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- April 16, 2024
- Registered through
- 2026
- Brand names listed
- FungalBlue, RedRenew Therapy Light, TFX LT2000, TFX-LT2000 Therapy Light
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis | PDZ | 2 | Complaint file establishment, Manufacturer | accessdata.fda.gov |
| Marker, Skin | FZZ | 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 |
|---|---|---|---|---|---|---|
| November 17, 2022 | K211265 | TFX-LT2000 Therapy Light | PDZ | Substantially Equivalent | Toefx, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Marker, Skin
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis
Updated November 17, 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.