Sofwave™ for the appearance of cellulite
What the FDA clearance covers
Sofwave™ is FDA cleared for a temporary reduction in the appearance of cellulite in adults aged 22 and older. Both words — temporary and appearance — are part of the cleared indication: by warming the mid-dermis at 1.5 mm to stimulate collagen and elastin, the overlying skin thickens so cellulite dimpling appears less pronounced.
How areas are assessed and treated
We evaluate the thigh or buttock area in consistent standing light before mapping the treatment grid. After topical numbing, the SUPERB™ handpiece is stamped across the dimpled zones over 30–45 minutes, with no downtime after your appointment.
Recommended sessions and expectations
A typical course for temporary reduction in the appearance of cellulite involves 1–2 sessions spaced 6–8 weeks apart, with smoother-looking surface texture developing over 8–12 weeks.
Sofwave, cleared as Sofwave System, is FDA cleared for improvement of facial lines and wrinkles, lifting the eyebrow, lifting lax submental and neck tissue, improvement of upper arm laxity, treatment of acne scars, and temporary reduction in the appearance of cellulite, in subjects aged 22 and older. 510(k) K250146
Aesthetic devices are cleared under FDA 510(k), which is not the same as approved. We cite the clearance so you can read the indication yourself. It describes the device, not any individual result — outcomes vary, and a consultation is what determines whether a treatment suits you.
