Ulthera's 2026 knee skin-laxity clearance: what changed

On May 21, 2026, the US Food and Drug Administration cleared the Ulthera System to improve the appearance of loose skin around the knees. The decision, K260618, concerns skin appearance rather than joint function. 1

The change is narrower than a new clearance for the whole body. Abdomen and anterior and posterior arm indications were already present in the earlier K250418 record. 2

What changed in the US indication list

This US 510(k) clearance does not establish Korean authorization or availability at a particular clinic. 1

For background on microfocused ultrasound with visualization, or MFU-V, see our overview of its evidence, safety and limitations.

What supports the knee indication?

The manufacturer's summary submitted to the FDA describes three knee studies with 44 subjects in total, assessed using several clinical endpoints. This is a summary of the submitted evidence, not a separate independent trial. 1

Published research predates the clearance. In 2014, Gold and colleagues described an open-label, nonrandomized knee study that enrolled 30 adult women; 28 were evaluable. That selected sample cannot tell every patient what result to expect. PubMed also links a 2015 corrigendum. 3

Why combination research needs a separate reading

A 2023 study by Juhász and colleagues enrolled 20 women and treated one leg with MFU-V plus dilute calcium hydroxylapatite filler. Sixteen completed the 24-week follow-up. The open-label study received funding and study product from Merz North America. 4

Clinician laxity ratings improved at 12 and 24 weeks. However, optical coherence tomography and 3D imaging did not show statistically significant improvement in the measured thickness-related or skin-surface outcomes. These exploratory measurements and the small sample limit interpretation. Mild adverse events, including bruising and swelling, were frequent. 4

Because both treatments were given, the study cannot establish the effect or adverse-event rate of ultrasound alone. Nor does the FDA's knee indication, by itself, establish clearance of this combined regimen. 14

Treatment boundaries and risks

The current PRIME instructions say not to treat a knee that has undergone an orthopedic procedure. Other contraindications include open wounds, severe or cystic acne in the area, active implants, and metallic implants in the treatment area. Pregnancy and breastfeeding are listed as unevaluated populations. 5

Body studies reported redness, swelling, bruising, pain, tenderness and welting. The label also lists postmarket reports such as burns, volume loss, scarring and nerve-related effects; voluntary reports cannot establish their frequency or causation. These reports are not a knee-specific risk estimate. 5

After knee treatment, sudden pain or loss of joint movement or function warrants medical attention under the label's safety advice. 5

Questions to bring to a consultation

Ask a board-certified dermatologist to explain the proposed device and local authorization, whether your concern is skin laxity, how your history affects suitability, and which alternatives deserve consideration. Ask what improvement would count as worthwhile, how it would be assessed, and what follow-up is available if symptoms develop.

A regulatory decision is a useful starting point for that conversation. The remaining decision depends on your concern, examination and preferences, with room to decide against a procedure.