The FDA has cleared Ultherapy PRIME for the treatment of skin on the knees, extending the microfocused ultrasound with visualization (MFU-V) platform beyond its established face and décolletage indications.

For Merz Aesthetics, the clearance broadens the addressable treatment area for a device that has built its reputation on non-invasive lifting of the brow, chin, neck and chest. The knee indication targets a patient population that has had few non-surgical options: loose or crepey skin on the knees, a complaint that grows with age and weight fluctuation and that has typically been addressed only with surgical lifts or energy devices used off-label.

For medical spas, dermatology practices and aesthetic clinics, the decision adds a new line to treatment menus. Knee laxity consultations can now be billed under an on-label indication, which matters both for marketing claims and for payer and compliance conversations. Practices already running Ultherapy PRIME can expand use of an installed device rather than invest in new capital equipment — a procurement consideration worth noting for clinics weighing device purchases this budget cycle.

The clearance also signals where the body-contouring and skin-tightening segment is heading. Regulators are increasingly evaluating energy-based devices on specific anatomical indications rather than blanket "body" claims, and manufacturers are responding by pursuing narrower, well-supported clearances. Expect competing ultrasound and radiofrequency platforms to follow with their own knee- and extremity-specific filings.

What to watch next: Merz's rollout timeline for the knee protocol, including recommended treatment parameters and pricing, and whether the company publishes clinical data supporting the indication — the detail that will determine how quickly adopting practices can set patient expectations credibly.