Last source review: 2026-09-09. This date does not mean that every specification has been verified.
At a glance
| Brand / company | CLASSYS [1] |
|---|---|
| Technology | Radiofrequency · RF |
| Energy category | Monopolar radiofrequency [1] |
| RF frequency (MHz) | 6.78 [1] |
| Wavelength (nm) | Not yet verified |
| Launch year | 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. [1] |
| Maximum average power (W) | 400 [1] |
Reading this record
A monopolar RF platform presented by CLASSYS. This record summarizes the manufacturer material linked below. It does not independently establish clinical effectiveness or local regulatory clearance.
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 ↗
Still to be checked
Numerical parameters, configuration-specific consumables, model history and market-specific regulatory records need separate document checks. An unverified field means the work is unfinished, not that the device lacks the feature.
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
Related devices
Articles about this device
- Monopolar RF: What the Device Filings Actually Say
Thermage FLX and Korea's Volnewmer list the same radiofrequency. Reading the 510(k) records and manufacturer specifications shows where the shared number stops explaining anything.