Merz's Ultherapy PRIME received FDA 510(k) clearance for treatment of skin laxity on the knees, marking the first regulatory approval for any device in this indication. The clearance expands the addressable market for microfocused ultrasound beyond the face and neck, where Ultherapy has dominated since its original 2009 clearance.
Devices & Tech
Ultherapy PRIME Clears FDA for Knee Skin
Merz's microfocused ultrasound wins first-ever FDA clearance for knee skin tightening.
First-ever FDA clearance for any device for knee skin tightening—a high-complaint area with minimal non-invasive options.
Knee skin laxity is a high-complaint area among aging patients—particularly women—and has historically been underserved by non-invasive options. The indication opens a new revenue stream for practices with existing Ultherapy platforms, though treatment protocols and patient selection criteria will require staff training. Real estate matters: knees are a lower-margin treatment zone compared to face/neck, but the procedure adds to patient lifetime value and cross-sell opportunity. Practices should expect Merz to bundle knee protocols into existing service packages and loyalty incentives.
Source: original report ↗
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