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Sofwave™ · SUPERB™ Ultrasound

Sofwave™ at Minori

Synchronous Ultrasound Parallel Beam (SUPERB™) technology at 1.5 mm mid-dermal depth — with all 6 FDA-cleared indications under 510(k) K250146 stated plainly.

What Sofwave™ is and why 1.5 mm matters

Sofwave™ uses 7 synchronous parallel ultrasound beams (SUPERB™ technology) to deliver controlled thermal energy at a precise 1.5 mm depth in the mid-dermis, where collagen and elastin fibers are densest. While the mid-dermis warms to 60–70°C to trigger neocollagenesis and neoelastogenesis, integrated Sofcool™ contact cooling protects the outer epidermis and deeper structures below 2 mm remain untouched.

All 6 FDA-cleared indications under 510(k) K250146

Under FDA 510(k) K250146 (cleared in 2025 for subjects aged 22 and older), Sofwave™ is cleared for 6 specific indications: 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. Each page below examines one cleared indication in detail.

What a session involves and when results develop

At Minori Skincare in NoMad, Manhattan, we apply topical numbing cream for 30–45 minutes before treatment. The ultrasound pass itself takes 30–45 minutes depending on the zones treated, with zero social downtime afterwards. Initial tightening can be felt within 1–2 weeks, while progressive collagen remodeling builds over 8–12 weeks.

Safe across all skin tones (Fitzpatrick I–VI)

Because ultrasound energy is absorbed acoustically at 1.5 mm rather than optically by melanin at the surface, Sofwave™ is safe across all Fitzpatrick skin types I–VI year-round. Explore the 6 treatment-area pages below to see how each indication is assessed at consultation.

Regulatory status

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.

Your skin's next chapter starts here.

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