| Primary Device ID | 00086001245602 |
| NIH Device Record Key | 75a008d8-92db-4712-b67f-a9492f269e31 |
| Commercial Distribution Status | In Commercial Distribution |
| Brand Name | TFX-LT2000 Therapy Light |
| Version Model Number | TFX-LT2000 |
| Company DUNS | 202099070 |
| Company Name | ToeFX Inc |
| Device Count | 1 |
| DM Exempt | false |
| Pre-market Exempt | true |
| MRI Safety Status | Labeling does not contain MRI Safety Information |
| Human Cell/Tissue Product | false |
| Device Kit | false |
| Device Combination Product | false |
| Single Use | false |
| Lot Batch | true |
| Serial Number | true |
| Manufacturing Date | true |
| Expiration Date | false |
| Donation Id Number | false |
| Contains Natural Rubber Latex | false |
| Labeled No Natural Rubber Latex | false |
| RX Perscription | false |
| OTC Over-The-Counter | false |
| Device Issuing Agency | Device ID |
|---|---|
| GS1 | 00086001245602 [Primary] |
| PDZ | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Steralize Prior To Use | false |
| Device Is Sterile | false |
| Public Version Status | New |
| Device Record Status | Published |
| Public Version Number | 1 |
| Public Version Date | 2024-11-25 |
| Device Publish Date | 2024-11-15 |
| 00860012465019 - FungalBlue | 2025-12-11 A temporary skin/nail-marking pen used by clinicians to outline areas of interest on the nail, including regions they plan to as |
| 00860012465033 - RedRevive | 2025-12-11 |
| 00086001245602 - TFX-LT2000 Therapy Light | 2024-11-25Light therapy device for onychomycosis |
| 00086001245602 - TFX-LT2000 Therapy Light | 2024-11-25 Light therapy device for onychomycosis |