Merz Aesthetics / Ulthera, Inc.
Ultherapy
A noninvasive microfocused-ultrasound platform that images tissue and deposits focal thermal-coagulation points at selected depths.
Microfocused ultrasound with visualizationReviewed 7/30/2026Source recorded
At a glance
| Primary purpose | Device-specific noninvasive lifting of brow and lax submental and neck tissue and improvement of décolletage lines under US clearances. |
|---|---|
| Mechanism | Real-time ultrasound imaging guides microfocused ultrasound energy to create discrete thermal-coagulation points at selected tissue depths, initiating a wound-healing and collagen-remodelling response. |
| When results appear | Manufacturer and clinical literature describe change developing over about 2 to 3 months and continuing up to 6 months. |
| Typical sessions | Often one treatment in manufacturer protocols; additional treatment depends on response and clinical plan. |
| Downtime | Usually no planned downtime; transient erythema, edema, tenderness, bruising, welts, or altered sensation can occur. |
| Longevity | Published reviews report improvement assessed out to roughly one year, while manufacturer materials say a year or longer; durability varies. |
| Reported discomfort | Published systematic reviews describe moderate treatment discomfort on average, with substantial patient and protocol variation. |
| Reversibility | Not reversible; deposited thermal-coagulation points cannot be removed. |
| Documented risks | Pain, redness, swelling, bruising, welts, transient numbness or weakness, burns, scarring, and contour change; correct depth and anatomy are critical. |
| Most common disappointment | The measured lift is generally modest and may not be visible enough for someone seeking surgical-level change. |
| Common marketing misconception | Treatment at a deep support layer is not equivalent to surgically repositioning that layer. |
| What varies by provider | Imaging, line count, transducer depth, vector planning, energy, tissue coupling, anatomy, and pain management. |
| Skin-tone considerations | Ultrasound is not melanin-targeted, but injury, burns, and post-inflammatory pigment change can still follow poor technique. |
| When this treatment may not be appropriate | Not appropriate for surgical-level laxity expectations or where IFU contraindications, open wounds, severe acne, or implanted devices in the treatment path apply. |
| United States regulatory status | FDA 510(k)-cleared through device-specific submissions including K121700 for brow, submental, and neck lifting and K134032 for décolletage lines. |
| Canadian regulatory status | Health Canada MDALL lists the Ulthera System under active Class III licence 79689. |
| Evidence status | High for device identity and cleared indications; moderate for modest efficacy and one-year durability, with heterogeneous protocols. |
Sources
- FDA 510(k) Summary K121700: Ulthera SystemFDA 510(k) summary · regulatory-primary · supports 13 profile fields
- FDA 510(k) Summary K134032: Ulthera SystemFDA 510(k) summary · regulatory-primary · supports 2 profile fields
- Health Canada MDALL: Ulthera SystemHealth Canada MDALL · regulatory-primary
- Systematic review and meta-analysis of microfocused ultrasoundpeer-reviewed systematic review · peer-reviewed-secondary
- Systematic review of microfocused ultrasound for facial rejuvenationpeer-reviewed systematic review · peer-reviewed-secondary
- Ultherapy 510(k) clearance summaryregulator
- Ultherapy Instructions for Useofficial manufacturer IFU · manufacturer-primary · supports 9 profile fields
- Ultherapy official patient informationofficial manufacturer information · manufacturer-primary
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