| Field | Thermage FLX ↗ | Volnewmer ↗ |
|---|---|---|
| Brand | Solta Medical | CLASSYS |
| Energy category | Radiofrequency (RF) Source ↗ | Monopolar radiofrequency Source ↗ |
| RF frequency (MHz) | 6.78 Source ↗ | 6.78 Source ↗ |
| Wavelength (nm) | Not yet verified | Not yet verified |
| Maximum average power (W) | 400 Source ↗ | 400 Source ↗ |
| Market-specific regulatory record | US FDA 510(k) K170758, found substantially equivalent on 2017-09-22. Applicant Solta Medical, regulation 21 CFR 878.4400, product codes GEI and ISA. The radiofrequency-only delivery components are indicated for dermatologic and general surgical procedures for electrocoagulation and hemostasis, non-invasive treatment of periorbital wrinkles and rhytids including upper and lower eyelids, and non-invasive treatment of wrinkles and rhytids. With simultaneous radiofrequency and skin vibration the record adds temporary improvement in the appearance of cellulite, relief of minor muscle aches and pains, relief of muscle spasms and temporary improvement of local circulation. The Korean MFDS record has not been checked. Source ↗ | 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 ↗ |
| Launch year | Not yet verified | Not yet verified |
| Tips / consumables | Treatment Tip. The 510(k) describes three sub-systems — console, handpiece and treatment tip — and lists the Return Pad, Skin Marking Grid Paper, Coupling Media, Cryogen and an optional Footswitch as accessories used during treatment. Source ↗ | 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 ↗ |
| Source review | 2026-09-09 | 2026-09-09 |
What the table establishes
A Thermage platform from Solta Medical using radiofrequency technology. A monopolar RF platform presented by CLASSYS. 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
- Thermage FLX — Solta Medical (Canada) ↗Manufacturer material · Accessed 2026-09-08
- FDA 510(k) K170758 — Thermage FLX System and Accessories (Solta Medical) ↗Regulatory record · Accessed 2026-09-09
- FDA 510(k) Summary K170758 — Thermage FLX System ↗Regulatory record · Accessed 2026-09-09
- 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