Sirona
The SIRONA 100 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via flexible fiber connected at one end…
The SIRONA 100 utilizes a solid-state diode as a semiconductor source for invisible infrared radiation. The energy is delivered to the treatment site via flexible fiber connected at one end to the laser source and the other end to the Handpiece. The device is activated by means of a footswitch or a finger switch on the handpiece.
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 | Wuhan Dimed Laser Technology Co., Ltd., China |
|---|---|
| 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 | Contract manufacturer, Complaint-file establishment, Manufacturer, Exporter |
| Record published | 2025-10-16 |
Specifications
| MRI safety | MR Safe |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SIRONA 100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| TFX-LT2000 Therapy Light | Toefx Inc. | 1 |
| 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 |
| 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.