[October Limited] Ultherapy & ONDA Double Chin Intensive Care 1 Session
Ultherapy Prime is a high density HIFU treatment that enhances the effects of Ultherapy. Ultherapy PRIME is the control unit Merz Aesthetics launched on 23 September 2024, holding its own U.S. 510(k) record (K233996). It delivers micro-focused ultrasound while the operator views tissue layers in real time; transducers are listed at 1.5 mm, 3.0 mm and 4.5 mm, and registration is decided country by country. Energy: Micro-focused ultrasound with visualization (MFU-V) U.S. 510(k): K233996 — Ulthera System (UC-1 Control Unit PRIME), decided 22 Feb 2024 Transducer depths: 1.5 mm / 3.0 mm / 4.5 mm Platform launch: Merz Aesthetics, 23 September 2024 Is Ultherapy PRIME a separate device or a new name for the same machine? PRIME is a separate hardware generation with its own U.S. device record, not a renamed version of the earlier unit. The FDA 510(k) database lists K233996 for the Ulthera System (UC-1 Control Unit PRIME), applicant Ulthera Inc., decided substantially equivalent on 22 February 2024 under product code OHV and 21 CFR 878.4590, and Merz Aesthetics announced the platform launch on 23 September 2024. What the manufacturer describes as changed is hardware and interface — treatments described as 20% faster, and a 35% larger screen with a faster image refresh rate — which are specification comparisons between machines and say nothing about how a treatment turns out. How does micro-focused ultrasound with visualization work?
Ultherapy Prime · Onda Lifting · Double Chin Fat-Targeting Injection
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