| Field | Volnewmer ↗ | Ultherapy PRIME ↗ |
|---|---|---|
| Brand | CLASSYS | Ulthera, Inc. |
| Energy category | Monopolar radiofrequency Source ↗ | Microfocused ultrasound Source ↗ |
| RF frequency (MHz) | 6.78 Source ↗ | Not yet verified |
| Wavelength (nm) | Not yet verified | Not yet verified |
| Maximum average power (W) | 400 Source ↗ | Not yet verified |
| Market-specific regulatory record | The manufacturer page states Korean MFDS approval (제허 22-512호) together with US FDA clearance. That approval number comes from manufacturer material and has not been cross-checked against the MFDS register. No corresponding FDA 510(k) number was located in the FDA database, so the US indications remain unverified. AccessGUDID lists the console and four tips under the labeler CLASSYS Inc. Source ↗ | US FDA 510(k) K233996, found substantially equivalent on 2024-02-22. Applicant Ulthera, Inc., regulation 21 CFR 878.4590, product codes OHV and IYO, Class II. The device name on the record is Ulthera System (UC-1 Control Unit PRIME) and the predicate is K180623. Indications: lift the eyebrow; lift lax submental and neck tissue, which can also affect the appearance of lax tissue in the submental and neck regions; improve lines and wrinkles of the décolleté. Used with the DeepSEE transducer the record covers ultrasonic visualization of depths up to 8 mm below the skin surface, for confirming transducer coupling and treatment depth. The Korean MFDS record has not been checked. Source ↗ |
| Launch year | Not yet verified | Not yet verified |
| Tips / consumables | I Tip 0.25 cm², F Tip 3.0 cm², V Tip 4.0 cm², S Tip 16.0 cm². The manufacturer also describes continuous water-cooled cooling. Source ↗ | Interchangeable transducers. The 510(k) describes the system as a control unit with system software, a handpiece with cable and interchangeable transducers. Source ↗ |
| Source review | 2026-09-09 | 2026-09-09 |
What the table establishes
A monopolar RF platform presented by CLASSYS. A platform described with microfocused ultrasound and real-time imaging. The verified difference here is the product identity and the energy description in the manufacturer materials.
Questions this table cannot answer
This overview cannot rank clinical results, comfort or value for an individual. Unverified numerical parameters, consumables and regulatory records need separate research. We do not infer a winner from missing data.
How to read a comparison →Sources reviewed
- CLASSYS — Introducing Volnewmer Monopolar RF Reinvented ↗Manufacturer material · Accessed 2026-09-08
- 클래시스 — 볼뉴머 제품 페이지 ↗Manufacturer material · Accessed 2026-09-09
- AccessGUDID — VOLNEWMER (CLASSYS Inc.) ↗Regulatory record · Accessed 2026-09-09
- Ultherapy PRIME — Merz Aesthetics ↗Manufacturer material · Accessed 2026-09-08
- FDA 510(k) K233996 — Ulthera System (UC-1 Control Unit PRIME) ↗Regulatory record · Accessed 2026-09-09
- FDA 510(k) Summary K233996 — Ulthera System Console Modifications ↗Regulatory record · Accessed 2026-09-09