System ONE-M
System ONE-M is classified and registered at the competent medical authority of Denmark as a Class I device according to Medical Device Directive 93/42/EEC by TOOsonix A/S.
Certification of the device by a Notified Body according to the Medical Device Regulation (EU) 2017/745 with an expanded intended purpose is on-going.
System ONE-M is intended for the following non-invasive aesthetic treatments:
- Angiomas (cherry spots and venous lakes)
- Solar Lentigines (liver spots)
- Telangiectasia (spider veins)
- Fine-line wrinkles
- Tattoo removal
See more information on indication for use here: Link
Handpieces are available in four different focal depts, optimized for different treatments.
Indication | Target Location | Recom. Handpiece | Treatment recommendations |
Angiomas (cherry spots) | Vascular structures proliferating from mid-dermis to surface | 1.3 mm | Full treatment covering entire angioma to close all capillary supplies. Cover edge by 1 – 2 additional shots outside angioma. |
Solar Lentigines (liver spots) | Residue melanocytes in upper dermis and epidermis | 0.8 mm / 1.3 mm | Partial treatment for partial wound formation to facilitate quick healing. |
Telangiectasia (spider veins) | Vascular structures in deep dermis and boundary to subcutis | 1.8 mm / 2.3 mm | Trace vascular structures with closely spaced treatment points to close vein entries/exits and vascular structure. |
Tattoo removal | Pigments in upper to middle dermis | 0.8 mm / 1.3 mm | Please see separate guidelines for treatment method and settings. |
Fine-line wrinkles | Injured fibers and collagen in deep dermis and boundary to subcutis | 2.3 mm | Larger thermal treatment points for dermal contraction and collagen restoration. |
Due to considerations to stable energy delivery at all times, handpieces are limited to 30 kJ energy dissipation, which is more than enough to get your treatment well established in the clinic before your first handpiece replacement becomes relevant. Each new system comes ready-to-use with a preinstalled software for intuitive control of the treatment from a responsive touchscreen PC, and furthermore provide a real-time dermascope-feed of the area under treatment for exceptionally accurate treatment. Two 20 MHz handpieces are included, which secures you can start treatments immediately after installation and training provided by a TOOsonix authorized representative.