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

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.

NCT Number	NCT07229430
Lead Sponsor	CLASSYS Inc.
Conditions	Skin Laxity (Submental and Neck), Facial Skin Laxity, Submental Tissue Laxity
Enrollment	273 participants
Start Date	2025-10-16
Primary Completion	2026-11-26 (estimated)
Study Completion	2026-11-26 (estimated)
Updated on ClinicalTrials.gov	2026-04-20