Non-invasive device gains FDA clearance
Aesthetic device brand Sofwave has announced the FDA clearance of its device, Superb, for the treatment of acne scars.
It has also released the details of the clinical study that it used to gain the clearance.
A total of 67 subjects were treated over four sites in the United States. Following three treatment sessions, 97% of treated subjects showed improvement in the appearance of acne scars. This was assessed by masked evaluators.
The study demonstrated a mean improvement level of 1.05±0.53 units based on the acne scar severity scale, which reflected an average improvement of 46% relative to the average baseline acne scar severity grading.
88% of the subjects reported improvement in their acne scars appearance.
The clinical study also demonstrated a favourable safety profile for the Superb system. No serious or unanticipated adverse events were reported during the study.
This new clearance adds to a range of treatments that have been FDA-cleared for Sofwave. In the US, its technology has been cleared for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, lax submental, and neck tissue, and for short-term improvement in the appearance of cellulite.
