FDA clears Ultherapy PRIME for knee skin laxity

Merz Aesthetics expands body indications while setting a sunset date for legacy devices.

The FDA cleared Ultherapy PRIME to improve the appearance of skin laxity on the knees on August 11, 2026, giving clinics the first energy-based aesthetic device indicated for this highly visible area to capture the growing body-tightening market. This new clearance expands the platform beyond its existing cleared applications for the face, neck, décolleté, abdomen, and arms. It allows providers to offer an authorized, non-invasive solution for patients experiencing skin changes due to weight loss, postpartum recovery, or menopause. Merz Aesthetics points to a nine percent compound annual growth rate in the skin-lifting market through 2030, driven heavily by these specific patient demographics.

Integrating knee treatments also provides a straightforward cross-selling opportunity for patients already receiving facial lifting. Rather than using off-label protocols, clinicians can now market an on-label, energy-based solution for knee laxity.

Operationally, this milestone comes with a firm timeline for capital planning. Merz Aesthetics is transitioning away from its legacy Ultherapy system. The manufacturer will end all service and technical support for the legacy device on September 30, 2027. For clinic owners, this means any existing older Ultherapy hardware has a defined expiration date for manufacturer backing. To continue offering these treatments with official support and to access the new knee indication, practices will need to budget for the Ultherapy PRIME upgrade within the next year.

Source: Modern Aesthetics, https://modernaesthetics.com/news/fda-clears-ultherapy-prime-for-skin-laxity-on-the-knees