The following data is part of a premarket notification filed by Toefx, Inc. with the FDA for Tfx-lt2000 Therapy Light.
| Device ID | K211265 |
| 510k Number | K211265 |
| Device Name: | TFX-LT2000 Therapy Light |
| Classification | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Applicant | ToeFX, Inc. 1280 Main Street West #039, Ste. B129 Hamilton, CA L8S 4M3 |
| Contact | Monika Yazdanian |
| Correspondent | Alexander Braun Henderson BraunSolutions Regulatory Group 970 South Dawson Way Unit 14 Aurora, CO 80012 |
| Product Code | PDZ |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-04-26 |
| Decision Date | 2022-11-17 |