TFX-LT2000 Therapy Light
Light therapy device for onychomycosis
5manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Hubei (3), Shanghai (2). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Jabil Circuit (Shanghai) Ltd. | Shanghai | Shanghai | Contract manufacturer | 31 |
| Wuhan Dimed Laser Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 3 |
| Gigaalaser Company Ltd. | Wuhan | Hubei | Contract manufacturer | 5 |
| LT Technology Limited | Jinqiao Export Processing Zone (South) | Shanghai | Manufacturer | 3 |
| Wuhan Phomed Technology Co., Ltd. | Wuhan | Hubei | Contract manufacturer | 2 |
Record
| Listed by | Toefx Inc., Canada |
|---|---|
| FDA product code | PDZ |
| Device type | Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4810 |
| Establishment | Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-11-15 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| TFX-LT2000 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Genesis Plus | Cutera, Inc. | 1 |
| Lightwalker AT | Fotona D.O.O. | 1 |
| Lunula | Erchonia Corporation | 1 |
| LightForce EXPi | LiteCure, LLC | 1 |
| Genesis Plus 1 mm Spot Size Adapter | Cutera, Inc. | 1 |
| LightForce EXP | LiteCure, LLC | 1 |
| Sirona | Wuhan Dimed Laser Technology Co., Ltd. | 1 |
| Hyperblue plus | Quanta System Spa | 1 |
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K211265 | 2022-11-17 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.