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 from Jeisys Medical is filed under GEI, electrosurgical cutting and coagulation devices and accessories. The record doesn't describe the device or say what "Prime" refers to.
Class II, 21 CFR 878.4400. The General and Plastic Surgery panel reviewed it as a Traditional 510(k).
Jeisys Medical filed from Seoul, South Korea. Review took 262 days (December 23, 2025 to September 11, 2026).
Clearance details
- Applicant
- Jeisys Medical Incorporated
- Product code
- Product 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
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More 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.