Non-Invasive · Focused Ultrasound · Skin Laxity

Ultherapy & HIFU

How this page was made
This page was written with AI assistance and reviewed against the sources listed under References below. It is general information only, not medical advice. See our full disclaimer for how SHEA creates and reviews treatment information.
01

What it is

Ultherapy is a specific focused-ultrasound treatment that combines microfocused ultrasound with real-time visualization (MFU-V). The ultrasound energy is delivered to selected depths beneath the skin, creating small points of thermal injury while leaving the skin surface largely unaffected.

Different transducers can target different tissue depths. With Ultherapy, this includes deeper tissue layers such as the superficial musculoaponeurotic system (SMAS). The resulting thermal injury is intended to trigger tissue remodeling over time.

“HIFU” is also widely used as a general name for aesthetic focused-ultrasound treatments, but these treatments are not one standardized product. Devices can differ in their technology, treatment depths, settings, regulatory status, and clinical evidence. Findings from Ultherapy studies should therefore not automatically be applied to every device marketed as HIFU.

02

Why people consider it

  • They are looking into a non-surgical treatment for mild to moderate skin or soft-tissue laxity
  • Areas commonly considered include the brow, beneath the chin, and the neck
03

What the experience is like

Focused ultrasound energy is delivered through a handpiece in a series of treatment lines or points. Treatment can be uncomfortable, and temporary pain or tenderness may occur. Pain-control approaches vary by clinic and treatment protocol.

With Ultherapy, changes are generally assessed over the following months rather than immediately after treatment. The exact treatment pattern, number of lines, depth, and settings depend on the treatment plan.

04

Limitations & considerations

  • Not everyone treated with focused ultrasound will have a noticeable aesthetic improvement
  • Results can vary with the device, treatment settings, treatment area, and individual response
  • For Ultherapy specifically, open wounds or lesions, severe or cystic acne, and active or metallic implants such as pacemakers or defibrillators in the treatment area are listed as contraindications
  • Ultherapy has not been evaluated in pregnant or breastfeeding women
  • More advanced skin laxity may not respond adequately to a non-surgical focused-ultrasound treatment and should be assessed individually
  • Safety instructions and contraindications can differ between devices, so they should be checked for the specific device being used
Evidence note
Ultherapy has specific US FDA-cleared indications to lift the eyebrow, lift lax submental and neck tissue, and improve lines and wrinkles of the décolletage. Published clinical studies have evaluated microfocused ultrasound with visualization for facial and neck laxity. The long-term study cited below followed 20 participants after a single MFU-V treatment for up to one year; it was an open-label pilot study sponsored by Merz Device Innovation Center.
Newer Ultherapy platform generations have received separate US FDA clearances, including indications beyond the facial, neck, and décolletage areas discussed on this page. Evidence and regulatory status should therefore be checked for the specific platform and treatment area being considered.
Evidence for other aesthetic focused-ultrasound devices should be considered separately. Differences in device design, treatment parameters, and available clinical studies mean that results reported for Ultherapy cannot be assumed to apply to every treatment marketed as HIFU.

References

Peer-reviewed literature, manufacturer safety information, and US regulatory records.

1. Fabi SG. Noninvasive skin tightening: focus on new ultrasound techniques. Clinical, Cosmetic and Investigational Dermatology, 2015;8:47–52.
Peer-reviewed · Clinical review · Author disclosed Ulthera consultancy
2. Werschler WP, Werschler PS. Long-term efficacy of micro-focused ultrasound with visualization for lifting and tightening lax facial and neck skin using a customized vectoring treatment method. Journal of Clinical and Aesthetic Dermatology, 2016;9(2):27–33.
Peer-reviewed · Open-label pilot study (n=20) · Manufacturer-sponsored
3. Ulthera, Inc. Ulthera System Instructions for Use — contraindications, precautions, and safety information.
Manufacturer safety information
4. US Food and Drug Administration. Ulthera System regulatory records — K072505, K121700, K134032, and K243035 (Ultherapy PRIME).
US regulatory
Scroll to Top