Last source review: 2026-09-09. This date does not mean that every specification has been verified.
At a glance
| Brand / company | Jeisys Medical [1] |
|---|---|
| Technology | RF microneedling |
| Energy category | RF microneedling (monopolar and bipolar) [1] |
| RF frequency (MHz) | 1, 2 [1] |
| Wavelength (nm) | Not yet verified |
| Launch year | Not yet verified |
| Tips / consumables | Single, insulated, semi-insulated (Tiger Tip) and Pumping tips. [1] |
Reading this record
An RF microneedling platform manufactured by Jeisys Medical. 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) K192545, found substantially equivalent on 2020-02-20. Applicant Jeisys Medical Incorporated, Seoul; regulation 21 CFR 878.4400; product codes GEI and OUH. The indications as filed read: intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Prescription use. The AccessGUDID labeler is also Jeisys Medical Inc. 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
- Cynosure — Potenza physician brochure ↗Manufacturer material · Accessed 2026-09-08
- FDA 510(k) K192545 — POTENZA (Jeisys Medical Incorporated) ↗Regulatory record · Accessed 2026-09-09
- FDA 510(k) Summary K192545 — POTENZA ↗Regulatory record · Accessed 2026-09-09
- AccessGUDID — POTENZA (Jeisys Medical Inc.) ↗Regulatory record · Accessed 2026-09-09
- Jeisys Medical — Potenza product page ↗Manufacturer material · Accessed 2026-09-09
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.