Equipment profile · Jeisys
Jeisys Density RF: Price, Specs, FDA Clearance and Alternatives
Density is Jeisys Medical’s needle-free RF skin-tightening system for practices weighing a Thermage-style treatment. It delivers monopolar and bipolar RF in the same pulse, and its first FDA clearance named Thermage FLX as the predicate device. Jeisys now sells it directly in the US.
The short answer
Density is FDA cleared for electrocoagulation and hemostasis, the same general use as Thermage FLX, which its 2023 clearance named as the predicate device. FDA’s comparison table lists the same 6.78 MHz frequency and 400 W maximum power. Jeisys now sells Density directly in the US but doesn’t publish a price.
Who should buy a Density?
Shortlist it if
- Needle-free tightening for the face, neck, eye area and body is a service you want to offer.
- You’re pricing Thermage and want a second option to compare.
- Jeisys commits in writing to US service and tip supply for your area.
Compare another option if
- You’d rather buy the long-established system with more US references: compare Thermage FLX.
- You want texture and scar work with needles: compare Jeisys’s Potenza.
Our take: Density or Thermage FLX?
Treat Density as a serious Thermage alternative to price, not a proven equal. The FDA record shows matching frequency and power, but that is a technical comparison, not a clinical one. The published Density studies are also small, and one author consults for Jeisys.
Ask for nearby US practices you can call, since Density is new here. Then compare total cost per treatment: tips by area, shots per tip, return pads, training and Jeisys’s written service terms against your Thermage quote.
Document-based buying analysis. Not a NuWays MD hands-on test of this device.
Density specifications at a glance
Before you compare
| Specification | Density | What it means for your practice |
|---|---|---|
| RF energy | 6.78 MHz; up to 400 W; monopolar and bipolar energy in the same pulse (manufacturer description) | The same frequency and maximum power as Thermage FLX in FDA’s comparison table. |
| Tips | Disposable treatment tips with a shot-life counter; the 2025 clearance added seven tips | Tips are the running cost. Price them by treatment area. |
| Return pad | Neutral electrode pad (cleared under K201685) | An extra disposable per treatment. |
| Cooling and control | Five cooling levels; real-time impedance monitoring; energy levels 0 to 8 in 0.5 steps; auto and manual modes | |
| Treatment areas | Face, jawline, neck, eye area and body (manufacturer) | |
| Model names | DENSITY, DENZA and DENSITY Noir appear in the 2025 FDA record | Confirm which model your quote names. |
Sources: FDA 510(k) K230663 · FDA 510(k) K250065 · Jeisys North America.
See it next to the alternativesSpecs, cleared uses and ownership questions in one table.
Density vs. Thermage FLX: what the FDA record compares
Jeisys’s 2023 FDA submission compared Density with Thermage FLX. The table shows what that record lists; it is not a clinical comparison.
| Feature | Density | Thermage FLX |
|---|---|---|
| Cleared use | Electrocoagulation and hemostasis | Electrocoagulation and hemostasis |
| Operating frequency | 6.78 MHz | 6.78 MHz |
| Maximum power | 400 W | 400 W |
| Energy delivery | Monopolar and bipolar in the same pulse (Jeisys) | Monopolar |
| Tips | Three types in 2023; seven more added in 2025 | Thermage FLX tips |
Sources: FDA 510(k) K230663 · FDA 510(k) K250065.
What is the Density FDA cleared for?
Each 510(k) number links to its record in the FDA database. The summary PDFs are listed under Sources.
510(k) K250065 (DENSITY; DENZA; DENSITY Noir), cleared July 8, 2025. Product code GEI; Class II medical device. Added seven tips that differ only in film design.
| Model | Cleared uses (summarized) |
|---|---|
| DENSITY, DENZA, DENSITY Noir | Dermatologic and general surgical procedures for electrocoagulation and hemostasis. |
Source: FDA 510(k) K250065.
510(k) K230663 (Density), cleared August 14, 2023. Product code GEI; Class II medical device. Cleared on equivalence to Thermage FLX (K170758).
Source: FDA 510(k) K230663.
Clearance describes what a device may be marketed for; it does not predict results for a given patient.
Density clinical studies
Published studies we found on this system, its earlier models and related technology, each labeled by what it tested. Most are small, and some have manufacturer-affiliated authors, so use them to frame questions for the demo rather than as proof of results.
What we found: 1 on this system, 1 on related technology.
- This systemReal-World Evaluation of Sequential Monopolar-Bipolar RF Device for RejuvenationProvider-rated improvement after sequential monopolar-bipolar RF. Jeisys lists it as Density research, and one author consults for Jeisys.
- Related technology: Jeisys sequential RF; model not namedSequential Monopolar-Bipolar Pulsed Radiofrequency for Non-Invasive Periorbital Rejuvenation: A Case SeriesEyelid-area tightening with a Jeisys sequential monopolar-bipolar RF system; one author consults for Jeisys.
Links open the PubMed record.
How much does a Jeisys Density cost?
| Price evidence | What we found |
|---|---|
| New system (manufacturer quote) | Jeisys does not publish a US price, and we found no reliable public price. |
| Used (asking prices) | Not reviewed for this profile. Density is new to the US, so few used units exist. |
| Documented sale prices | None found. |
What ownership adds after purchase
| Cost area | What to confirm |
|---|---|
| Tips | Each tip has a set shot life. Get per-tip prices, shots per tip and minimum orders. |
| Return pads | A neutral electrode pad per treatment. |
| US support | Get service response times, parts and tip supply in writing from Jeisys North America. |
| Training and safety | RF can burn; budget provider training, consent and complication management. |
Density alternatives to compare
| Device | Technology | Why compare it |
|---|---|---|
| Solta Medical Thermage FLX | Monopolar RF, 6.78 MHz | The monopolar RF system named as the predicate in Density’s FDA record. |
| Merz Aesthetics Ultherapy PRIME | Microfocused ultrasound with visualization | Ultrasound skin tightening with imaging, a different energy type. |
| Jeisys Potenza | RF microneedling | Jeisys’s RF microneedling for texture and scars rather than needle-free tightening. |
Different technologies are not interchangeable. Compare configurations, cleared uses and ownership costs before you book demos.
Questions to ask before you sign
- Density, Denza or Density Noir, and which tips are included?
- What does each tip cost, how many shots does it hold, and what is the minimum order?
- Who services the system and supplies tips in the US, and for how long is that committed in writing?
- What does the warranty cover, and how many training days are included?
- What is the total with tax, freight, installation and financing?
Plan the purchase
Plan your Density purchase.
- Compare it side by side with its closest alternatives.
- Check what each quote includes: configuration, supplies, service and financing.
- Model the monthly payment against realistic treatment volume in the ROI calculator.
Other skin tightening machines to research
InModeDefineFull profileHands-free and handheld bipolar RF plus Morpheus8Read the full page →
Solta MedicalThermage FLXFull profileMonopolar RF, 6.78 MHzRead the full page →
Merz AestheticsUltherapy PRIMEFull profileMicrofocused ultrasound with visualizationRead the full page →
BTLEMFACEFull profileSynchronized RF and HIFES facial muscle stimulationRead the full page →All skin tightening machines →More Jeisys equipment →Full equipment catalog →
Sources
Show all 4 sources
- Jeisys North America: Density (November 7, 2026). Checked November 7, 2026.
- Jeisys North America (November 7, 2026). Checked November 7, 2026.
- FDA 510(k) K230663: Density (August 14, 2023). Checked November 7, 2026.
- FDA 510(k) K250065: DENSITY; DENZA; DENSITY Noir (July 8, 2025). Checked November 7, 2026.