Potenza Prime
Jeisys Medical Incorporated · General, Plastic Surgery
Open FDA's page for this record- Third party flag
- N
- City
- Seoul
- Advisory committee description
- General, Plastic Surgery
- Address 1
- 307 Daeryung Techno Town 8th
- Address 2
- Gamasan-Ro 96, Geumcheon-Gu
- Statement or summary
- Summary
- Product code
- GEI
- Zip code
- 08501
- Applicant
- Jeisys Medical Incorporated
- Decision date
- 2026-09-11
- Decision code
- SESE
- Country code
- KR
- Device name
- Potenza Prime
- Advisory committee
- SU
- Contact
- HeeKyung Kim
- K number
- K254185
- Date received
- 2025-12-23
- Review advisory committee
- SU
- Postal code
- 08501
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Electrosurgical, Cutting & Coagulation & Accessories
- Medical specialty description
- General, Plastic Surgery
- Regulation number
- 878.4400
- Device class
- 2
- Registration number
- 2184009, 1221934, 3013176080, 9680952, 3003678543, 3009380063, 3009881188, 2245590, 2431166, 3006849754, 2029275, 3004111573, 2133786, 3009882464, 3013283620, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 1836161, 2020394, 1222993, 3006891627, 9610614, 2955842, 3011879048, 3013466775, 2032098, 3004636440, 3012790575, 9614969, 3007583504 +832 more
- FEI number
- 1221934, 3013176080, 3003678543, 3009380063, 3009881188, 2245590, 3006849754, 3004111573, 3009882464, 3013283620, 3002808445, 3012447612, 3007710878, 2648623, 3004122598, 3015612252, 3010280625, 1929938, 3012497308, 3009762450, 3010288205, 3012322232, 3018242561, 2020394, 3006891627, 1000518731, 3011879048, 1000112877, 3013466775, 1000160458, 3002900199, 1000122656, 3003186357, 3004636440, 3012790575, 3007583504, 3040335671, 3009420598, 3010164891, 3003448211 +832 more