Potenza Prime
FDA 510(k) K254185 · Jeisys Medical Incorporated
510(k) numberK254185
Submission
- Device name
- Potenza Prime
- Applicant
- Jeisys Medical Incorporated
Seoul, KR - Received
- December 23, 2025
- Decision date
- September 11, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
Other 510(k)s with product code GEI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K262364 | Ellian Enigma RF DeviceGEI · Traditional | Ellian Corp | 09/02/2026SE |
| K253859 | Scarlet Pro (Scarlet Pro)GEI · Traditional | VIOL Co., Ltd. | 08/27/2026SE |
| K252535 | Inno-Switch Laparoscopic InstrumentsGEI · Traditional | Taiwan Surgical Corporation | 08/25/2026SE |
| K261179 | AlphaTriPart - Monopolar MIC InstrumentsGEI · Traditional | Gimmi GmbH | 07/22/2026SE |
| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
| K254056 | THUNDERBEAT 5 mm, 45 cm, Front-actuated Grip Type S (TB-0545FCS); THUNDERBEAT 5 mm, 35…GEI · Traditional | Olympus Medical Systems Corp. | 07/01/2026SE |
| K253484 | Lutronic GeniusGEI · Traditional | Cynosure Lutronic Technology Corporation | 06/29/2026SE |
| K251492 | Irrigation Tubing Bipolar Cord SetGEI · Traditional | New Deantronics Taiwan , Ltd. | 06/29/2026SE |
| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
| K253634 | CoolSeal Generator® (CSL-200-90)GEI · Traditional | Hologic, Inc. | 06/17/2026SE |
More from Hologic, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K251464 | TRI-BEAM PRO, TRI-BEAM (Nd:YAG Laser unit)GEX · Traditional | 10/03/2025SE |
| K250065 | DENSITY; DENZA; DENSITY NoirGEI · Traditional | 07/08/2025SE |
| K231216 | PotenzaGEI · Traditional | 12/10/2024SE |
| K231287 | PotenzaGEI · Traditional | 11/05/2024SE |
| K230663 | DensityGEI · Traditional | 08/14/2023SE |
| K223685 | SmoothCool HR SystemGEX · Special | 01/04/2023SE |
| K213484 | SmoothCool HR SystemGEX · Special | 04/20/2022SE |
| K201685 | PotenzaGEI · Traditional | 01/19/2021SE |
| K192545 | PotenzaGEI · Traditional | 02/20/2020SE |
| K183284 | INTRAcel RF Microneedle SystemGEI · Traditional | 01/15/2020SE |
Questions and answers
When was Potenza Prime cleared by the FDA?
Potenza Prime (K254185) received a 510(k) decision of Substantially Equivalent on September 11, 2026, 262 days after the submission was received.
What is the product code of K254185?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.