| Field | Thermage FLX ↗ | Ultherapy PRIME ↗ |
|---|---|---|
| Brand | Solta Medical | Ulthera, Inc. |
| Energy category | Radiofrequency (RF) 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 | 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 ↗ | 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 | 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 ↗ | 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 Thermage platform from Solta Medical using radiofrequency technology. 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
- 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
- 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