Last source review: 2026-09-09. This date does not mean that every specification has been verified.
At a glance
| Brand / company | Solta Medical [1] |
|---|---|
| Technology | Radiofrequency · RF |
| Energy category | Radiofrequency (RF) [1] |
| RF frequency (MHz) | 6.78 [1] |
| Wavelength (nm) | Not yet verified |
| Launch year | 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. [1] |
| Maximum average power (W) | 400 [1] |
Reading this record
A Thermage platform from Solta Medical using radiofrequency technology. This record summarizes the manufacturer material linked below. It does not independently establish clinical effectiveness or local regulatory clearance.
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 ↗
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
- 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
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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.