510(k) clearance
Potenza Prime
- 510(k) number
- K254185
- Applicant
- Jeisys Medical Incorporated
- Decision date
- Sep 11, 2026
- Date received
- Dec 23, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- GEI
- Device type
- Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II
- Regulation
- 21 CFR 878.4400
- Advisory committee
- General, Plastic Surgery
- Statement or summary
- Summary
- Third party
- N
- Location
- Seoul, KR