FDA Clears Ultherapy PRIME for Lifting Knee Skin Laxity

On August 11, 2026, the FDA cleared Merz Aesthetics' Ultherapy PRIME device to improve the appearance of skin laxity on the knees, making it the first and only energy-based aesthetic device indicated for this area. For your practice, this opens up a highly requested treatment area as an on-label, clinically backed offering. The system uses microfocused ultrasound with vivid real-time visualization (MFU-V) to target tissue layers precisely, stimulating collagen and elastin production where skin sagging above the kneecap is notoriously difficult to treat. Alongside this new indication, Merz is executing a hardware transition that directly affects capital equipment planning. The company is phasing out the legacy Ultherapy platform, with all service and support for the older device scheduled to conclude on September 30, 2027. If you are currently operating the legacy system, you will need to plan for an upgrade to the PRIME platform before that deadline to maintain manufacturer support while gaining the ability to market this new, FDA-cleared knee-lifting protocol.

Source: MedEsthetics, https://www.medestheticsmag.com/companies/news/22026011/ultherapy-prime-becomes-first-fdacleared-device-for-knee-skin-lifting