Lightwalker AT
Catalogue number M021-5AF/1, listed by Fotona D.O.O., Slovenia, under Lasers For Temporary Increase Of Clear Nail In Patients With Onychomycosis. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
1catalogue number
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 | Fotona D.O.O., Slovenia |
|---|---|
| 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 | Manufacturer |
| Record published | 2016-09-19 |
| Record revised | 2025-07-14 (version 6) |
Specifications
| MRI safety | MR Safe |
|---|---|
| Label carries | manufacturing date, serial number |
| Storage | Handling environment humidity 30 to 75 % RH; Handling environment atmospheric pressure 700 to 1060 KiloPascal; Storage environment atmospheric pressure 500 to 1060 KiloPascal; Handling environment temperature 10 to 25 °C; Storage environment humidity 10 to 100 % RH; Storage environment temperature -40 to 70 °C |
| Distribution end date | 2021-11-30 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| M021-5AF/1 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TFX-LT2000 Therapy Light | Toefx Inc. | 1 |
| Genesis Plus | Cutera, Inc. | 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 |
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.