The Danish company also scored a CE Mark for the HIFU system.

TOOsonix A/S is launching its CE-marked System ONE-M for color-independent tattoo removal, solar lentigines, spider veins, angiomas, telangiectasia and other aesthetic conditions.

System ONE-M is a focused ultrasound device operating at 20 MHz, which creates thermal lesion points in the upper dermis and epidermis of the human skin. Within the focal point, the temperature rapidly increases to 50–60 °C, which introduces acute cell necrosis. The body’s own immune system may thereby become activated to remove and replace affected cells with new and healthy cells.

The launch coincides with the publication of two papers in Skin Research and Technology describing positive results from the first clinical treatments performed at the Bispebjerg University Hospital, Copenhagen, Denmark by Jørgen Serup, MD.

“In our experimental work we have furthermore, demonstrated that the device used for Actinic Keratosis has important advantages over photodynamic therapy (PDT), practically, resource-wise, and with respect to efficacy,” Dr. Serup says in a news release. “Noteworthy is the reduced pain-level during treatment. HIFU can be applied to multiple sites of the body in one short session and, obviously, has the potential to replace PDT in the future. Experimental use indicates the device can be used for dedicated ablative treatment of skin cancers, particularly basal cell carcinoma, and for a range of different premalignant conditions as well as a multitude of benign skin tumors. The method is an entirely new treatment modality in dermatology, with a large potential”.

"The CE marking of our first medical device…is the first important step in TOOsonix’ vision to make new and advanced HIFU systems available for dermatological use all over the globe,” states Torsten Bove and Tomasz Zawada, co-founders of TOOsonix, in a news release. "We initially intend to offer this device to first-mover dermatologists within the European Union, and look forward to the resulting physician feedback and market data that can guide our addition of more medical indications in the future”.