Potenza Prime— 510(k) K254185
Substantially EquivalentJeisys Medical Incorporated
FDA 510(k) clearance K254185 for Potenza Prime, Substantially Equivalent on 2026-09-11. Applicant: Jeisys Medical Incorporated. Device class: 2.
Summary
Potenza Prime is filed under GEI, electrosurgical cutting and coagulation devices. Potenza is Jeisys Medical's radiofrequency microneedling line, and RF microneedling systems routinely clear under GEI. The record doesn't say what "Prime" changes.
Class II, 21 CFR 878.4400. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Jeisys Medical filed from Seoul. Review took 262 days (December 23, 2025 to September 11, 2026), longer than most GEI clearances. GEI is one of FDA's busiest codes, and a timeline like this often means questions about energy delivery or how the indications are worded.
Clearance details
- Applicant
- Jeisys Medical Incorporated
- Product code
- Code GEI
- Device class
- Class 2
- Regulation
- 21 CFR 878.4400
- Advisory panel
- General, Plastic Surgery
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Seoul, KR
Recent devices under product code GEI
view allMore clearances from Jeisys Medical Incorporated
view allAdverse events under product code GEI
product code GEI- Death
- 133
- Injury
- 7,585
- Malfunction
- 35,808
- Other
- 44
- Total
- 43,570
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.