Safety and Effectiveness Evaluation of the High-intensity Focused Ultrasound Device for Lifting Lax Submental and Neck Tissue

Conditions

• Facial Skin Laxity
• Skin Laxity (Submental and Neck)
• Submental Tissue Laxity

Eligibility Criteria

Sex

ALL

Age

30 Years - 65 Years

Healthy Volunteers

Accepted

Interventions

• ULTRAFORMER MPT PLUS — DEVICE
  ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) is a high-intensity focused ultrasound (HIFU) system that delivers focused energy at multiple depths to induce neocollagenesis and tissue contraction for non-surgical lifting and tightening of submental and neck tissue. The device includes both Default and MP modes and is under investigation under FDA IDE G250041.
• Ulthera System — DEVICE
  The Ulthera System (Merz Aesthetics, USA) is an FDA-cleared high-intensity focused ultrasound (HIFU) device indicated for non-invasive lifting and tightening of lax tissue in the submental and neck areas. It serves as the active comparator for this non-inferiority clinical study.

Study Details

This is a prospective, multicenter, randomized, evaluator-blinded, parallel-controlled, non-inferiority clinical study designed to evaluate the safety and effectiveness of the ULTRAFORMER MPT PLUS, a high-intensity focused ultrasound (HIFU) device, for lifting and tightening lax submental (beneath the chin) and neck tissue in adult subjects. Approximately 273 subjects will be enrolled at multiple investigational sites across the United States. Participants will receive either the ULTRAFORMER MPT PLUS treatment or the predicate comparator device, and will be followed for safety and efficacy assessments including clinical photography, investigator evaluation, and patient-reported outcomes. The study aims to demonstrate that ULTRAFORMER MPT PLUS is non-inferior to the approved reference device in improving skin laxity and wrinkle appearance of the lower face and neck.

Key Dates

Start date

Oct 16, 2025

Status verified

Apr 2026

Primary completion

Nov 26, 2026

Completion

Nov 26, 2026

Study Design

Enrollment

273 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: ULTRAFORMER MPT PLUS Group
  ULTRAFORMER MPT PLUS (Classys Inc., Seoul, Korea) delivers high-intensity focused ultrasound (HIFU) energy to the subdermal tissue to induce neocollagenesis and tissue contraction for non-surgical skin tightening and lifting.
• Active Comparator: Ulthera Comparator Group
  The Ulthera® System (Merz Aesthetics, USA) uses focused ultrasound energy to lift and tighten submental and neck skin and serves as the reference comparator in this non-inferiority clinical trial.

Primary Outcome Measure

Submental Area Lift [Time Frame: 90 Days Post-Treatment] [ Time Frame: 90 Days Post-Treatment ]

Central Contacts

• Megan Kim
  +82-10-3723-4829
  [email protected]
• James Lim
  [email protected]

Locations (5)

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