The Ulthera system is FDA approved. It is a non-invasive aesthetic treatment that uses MFU-V for skin lifting and tightening. It combines MFU with high-resolution ultrasound imaging so that the practitioner can see the layers of tissue and ensure that the energy is being delivered to the correct layer to produce the desired result.
A study called "Micro focused ultrasound with visualisation: Consensus on safety and review of energy-based devices" concludes that "the independent test results of MFU-V/HIFU devices and the consensus panel conclusions provide strong support that real-time visualisation and the capability to detect coupling, features found only in MFU-V, help prevent complications and enhance the safety and effectiveness of energy-based devices. The independent evaluation also revealed that MFU-V has several additional features that play key roles in safety and clinical effectiveness, including uniformity of TCPs, tight thermal regulation, large focal gain, and short beam length, that were not found collectively in any of the HIFU devices."
Reference: Pavicic T, Ballard JR, Bykovskaya T, Corduff N, Hirano C, Park JY, Saromytskaya A, Sevi J, Vasconcelos S. Micro focused ultrasound with visualisation: Consensus on safety and review of energy-based devices. J Cosmet Dermatol. 2022 Feb;21(2):636-647. DOI: 10.1111/jocd.14666. Epub 2021 Dec 24. PMID: 34951735.