Potenza Prime

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 11, 2026 Jeisys Medical Incorporated % Connie Hoy Consultant Hoy & Associates Regulatory Consulting, LLC 1830 Bonnie Way Sacramento, California 95825 Re: K254185 Trade/Device Name: Potenza Prime Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI, OUH Dated: August 9, 2026 Received: August 10, 2026 Dear Connie Hoy: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254185 - Connie Hoy Page 2 Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K254185 - Connie Hoy Page 3 Sincerely, Colin K. Chen -S Digitally signed by Colin K. Chen -S Date: 2026.09.11 14:46:21 -04'00' Colin K. Chen, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. 510(k) Number (if known) K254185 Device Name Potenza Prime Indications for Use (Describe) The Potenza Prime is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, the DDR tips are limited to Fitzpatrick Skin Types I-IV. Type of Use (Select one or both, as applicable) ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) # CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF {4} # 510(k) SUMMARY K254185 Prepared in accordance with 21 CFR 807.92 ## 1. Submitter Information | **Submitter (Legal Manufacturer)** | Jeisys Medical Incorporated | | --- | --- | | **Address** | 307 Daeryung Techno Town 8th Gamasan-ro 96, Geumcheon-Gu Seoul 08501 Korea, Republic of Korea | | **Telephone** | +1-82 10 3767 0590 | | **Contact Person** | Ms. HeeKyung Kim, Head of Regulatory Compliance | | **Contact Telephone** | +1-82 10 3767 0590 | | **Contact E-mail** | hkkim@jeisys.com | | **Date Summary Prepared** | August 9, 2026 | ## 2. Device Identification | **Trade / Proprietary Name** | Potenza Prime | | --- | --- | | **Common / Usual Name** | Electrosurgical cutting and coagulation device and accessories | | **Classification Name** | Electrosurgical, cutting & coagulation & accessories | | **Regulation Number** | 21 CFR 878.4400 | | **Product Code(s)** | GEI, OUH | | **Regulatory Class** | Class II | | **Review Panel** | 79-General and Plastic Surgery | ## 3. Predicate and Reference Devices ### 3.1 Primary Predicate | **510(k) Number** | K231216 | | --- | --- | | **Applicant / Manufacturer** | Jeisys Medical Corporation | | **Trade / Device Name** | Potenza | Page 1/7 {5} # 510(k) SUMMARY # K254185 Prepared in accordance with 21 CFR 807.92 | Regulation Number | 21 CFR 878.4400 | | --- | --- | | Regulation Name | Electrosurgical, cutting & coagulation & accessories | | Regulatory Class | Class II | | Product Code | GEI, OUH | # 3.2 Additional Predicate or Reference Device(s) | 510(k) Number | K231286 | | --- | --- | | Applicant / Manufacturer | Jeisys Medical Corporation | | Trade / Device Name | Potenza | | Product Code | GEI, OUH | | Role | Predicate | # 4. Device Description The Potenza Prime is a next generation model of the previously clear Potenza. This device is used for coagulation using high frequency current. The Potenza Prime consists of main body, 3 handpieces( Motor Handpiece / S Handpiece / AC Handpiece), handpiece stand, disposable electrodes, neutral electrode, neutral electrode cable, foot switch and power cord, and is controlled by software. There are 11 disposable electrodes included in this submission. Of the 11 , there are 7 that are invasive (microneedles), and 4 that are non-invasive. # 5. Indications for Use The Potenza Prime is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, the DDR tips are limited to Fitzpatrick Skin Types I-IV. Page 2/7 {6} # **510(k) SUMMARY** **K254185** Prepared in accordance with 21 CFR 807.92 # **6. Comparison of Technological Characteristics** The subject device is compared to the predicate device in the table below. Characteristics are identified as the same or different; each difference is addressed in the discussion that follows. Page 3/7 {7} # 510(k) SUMMARY # K254185 Prepared in accordance with 21 CFR 807.92 | | Subject | Predicate K231216 | Comparison | | --- | --- | --- | --- | | Appearance | | | Different The difference is cosmetic only | | Principal of Operation | Monopolar or bipolar RF energy is delivered through micro needle electrode applying heat to target tissue to achieve coagulation and hemostasis | Monopolar or bipolar RF energy is delivered through micro needle electrode applying heat to target tissue to achieve coagulation and hemostasis | Same | | Operating Mode | Monopolar and Bipolar | Monopolar and Bipolar | Same | | Output Frequency | 1 MHz | 1 MHz / 2 MHz | Same. The subject device operates at 1MHz only. The specification for the 1MHz is the same. | | Nominal Operating | 0 ~ 50 watt (step: 1 watt) | 0 ~ 50 watt (step: 1 watt) | Same | Page 4/7 {8} # 510(k) SUMMARY ## K254185 Prepared in accordance with 21 CFR 807.92 | | Subject | Predicate K231216 | Comparison | | --- | --- | --- | --- | | Power | | | | | Maximum Power Delivered to Patient | up to 50 W (step: 1 watt) (200 Ω) | up to 50 W (step: 1 watt) (200 Ω) | Same | | Impedance | 200 Ω | 200 Ω | Same | | Power Source | 100 V - 240 V~, 50/60 Hz, 500 VA | 100 V - 240 V~, 50/60 Hz, 500 VA | Same | | Dimensions (mm) | 503.2 (W) x 365.6 (L) x 316 (H) | 503.2 (W) x 365.6 (L) x 316 (H) | Same | | Weight | 12.5 kg | 12.5 kg | Same | | Neutral Electrode Pad | | | | | | Neutral Electrode Pad for monopolar operation, K201685 | Neutral Electrode Pad for monopolar operation, K201685 | Same | | Footswitch | - | - | | | Function | Transmit RF energy to electrode | Transmit RF energy to electrode | Same | | Performance | Single pole, single throw | Single pole, single throw | Same | | Materials | Steel and plastic | Steel and plastic | Same | | Other Characteristics | Single pedal, IPX8 | Single pedal, IPX8 | Same | Technical Comparison for the RF Microneedling Tips | Active Accessory (Electrode) | Subject | Predicate K231216 | - | | --- | --- | --- | --- | | Operating Mode | Monopolar / Bipolar | Monopolar / Bipolar | Same | Page 5/7 {9} # 510(k) SUMMARY ## K254185 Prepared in accordance with 21 CFR 807.92 | Active Accessory (Electrode) | Subject | Predicate K231216 | - | | --- | --- | --- | --- | | Electrode Tips | Four different electrode tips for the motor handpiece: ACS-I25, PTP-I16, PMP-I16, PMP-I25 Five different electrodes for the S Handpiece: DIA-F, SFA-E, SFA-F, DDR-R, DDR-E One electrode tip for the AC handpiece: One-A Needle | Ten different electrode tips for the motor handpiece: S-49 TIP, I-49 TIP S-25 TIP, I-25 TIP, S-16 TIP, and I-16 TIP, C21-2 TIP, C21-1 TIP, CP-21 TIP, and C9 TIP Three electrode needle tips for the AC handpiece: P1-08, A1-12, and A1-15 Three electrode tips for the motor handpiece: CP-16 TIP, CP-25 TIP and CP-49 TIP. | Different A detailed explanation of the similarities and differences are in the tables below *, **, *** | | Electrode Type | Micro needle type | Micro needle type | Same | | Electrode Tip Shelf-life | 1 Years | 2 Years | The shelf life was only tested to 1 year at this time | | RF Treatment Area | Spot Size (Treated area): 1 cm x 1cm | Spot Size (Treated area): 1 cm x 1cm | Same | | Enhanced engagement with tissue | Piston Mechanism | Piston Mechanism | Same | | Material | Housing: Polycarbonate Insulation: Paracyclophane Needles: STS304 | Housing: Polycarbonate Insulation: Paracyclophane Needles: STS304 | Same | | Single Use / Reusable | Single use | Single use | Same | Page 6/7 {10} # 510(k) SUMMARY K254185 Prepared in accordance with 21 CFR 807.92 | Active Accessory (Electrode) | Subject | Predicate K231216 | - | | --- | --- | --- | --- | | Method of Sterilization | Ethylene Oxide gas (EO) | Ethylene Oxide gas (EO) | Same | | Depth of Skin Ablation / Thickness | Depth of skin ablation: 0.5 ~ 4.0 mm (step: 0.25 mm) Thickness: 0.2 mm | Depth of skin ablation: 0.5 ~ 4.0 mm (step: 0.25 mm) Thickness: 0.2 mm | Same | | Max insertion depth | 4.0mm | 4.0 mm | Same | | Min insertion depth | 0.5mm | 0.5mm | Same | | Thickness of the needle | 0.25mm | 0.25mm | Same | | Max Power | 50W | 50W | Same | ## Comparison of the invasive RF Microneedling tips | Description | Subject tip Name | Predicate tip name (231216) | Comparison | | --- | --- | --- | --- | | 16 needle insulated | PTP-I16 | I16 | Same | | 25 needle insulated | ACS-I25 | I25 | Same | | 16 needle | PMP-I16 | CP-16 | Same | | 25 needle | PMP-I25 | CP-25 | Same | | Single needle | ONE_A | A1-12 | Same | ## Comparison of the non-invasive RF Microneedling tips | Subject Description | Subject Tip Name | Predicate tip name (231287) | Comparison | | --- | --- | --- | --- | | 16 pins | SFA-F | SFA | Different. The number of pins is different | | 12 pins | SFA-E | SFA | Different. The number of pins is different | | 64 pins | DDR-E | DDR | Different. The number of pins is different | | 49 pins | DDR-R | DDR | Different. The number of pins is different | | 16 pins | DIA-F | DIAMOND | Same | Page 7/7 {11} # 510(k) SUMMARY # K254185 Prepared in accordance with 21 CFR 807.92 # 6.1 Discussion of Differences The main console for the Potenza Prime is identical to the predicate device with two exceptions: - The Potenza Prime has a different cosmetic appearance - The Potenza Prime only operates at 1MHz whereas the predicate device operates at 1MHz and 2MHz. The operation of the 1MHz mode is identical to the predicate device. The predicate device part number SFA had only one configuration while the subject device has two configurations with different numbers of pins. Pictures of the configurations for the SFA Tip | | Predicate SFA tip which is 8 x 24 pins | | --- | --- | | | Subject SFA-F tip which is 8 x 8 pins | | | Subject SFA-E tip which is 2 x 6 pins | The predicate device part number DDR had only one configuration while the subject device has two configurations with different numbers of pins. Pictures of the configurations for the DDR Tip | | Predicate DDR tip which is 6 x 6 pins | | --- | --- | Page 8/7 {12} # 510(k) SUMMARY K254185 Prepared in accordance with 21 CFR 807.92 | | Subject DDR-R -Tip which is 7 x 7 pins | | --- | --- | | | Subject DDR-E tip which is 2 x 2 pins | Thermal testing was conducted per the FDA guidance Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery. The report concludes that the new tip configurations are safe and do present coagulation as expected. The conclusion is that the new configurations of the non-invasive electrode tips do not raise any new concerns for safety and efficacy and are substantially equivalent to the predicate device. ## 7. Performance Data ### 7.1 Performance Characteristics Verification and validation activities confirmed that the addition of four new electrode tips for the motor handpiece do not raise new or different questions of safety or effectiveness. Testing confirmed the continued conformance to applicable technical design specifications and performance requirements including conformance to requirements of recognized consensus standards. ### 7.2 Biocompatibility Testing Jeisys performed biocompatibility testing for the four newly added electrode tips according to FDA's "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a risk management process'', June 6, 2016. The electrode tips are external communicating devices which come into contact with tissue / bone / dentin, for a limited period of time, i.e., less than 24 hours. The electrode tips were tested as shown in Table 1 below. Page 9/7 {13} # **510(k) SUMMARY** **K254185** Prepared in accordance with 21 CFR 807.92 | Test Type | Standard | Results | | --- | --- | --- | | Cytotoxicity | ISO 10993-05:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity | Pass | | Sensitization : Guinea Pig Maximization Test | ISO 10993-10:2021 Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization | Pass | | Irritation or Intracutaneous Reactivity | ISO 10993-23: Biological Evaluation of Medical Devices: Test for irritation, 2021 | Pass | | Acute Systemic Toxicity | ISO 10993- 11: Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity, 2017 | Pass | | Material Mediated Pyrogen Test | ISO 10993- 11: Biological Evaluation of Medical Devices- Part 11: Tests for Systemic Toxicity, 2017 | Pass | | In-vitro Hemolysis Test direct contact method | ISO 10993-04: Biological Evaluation of Medical Devices - Part 04, Selection of Tests for Interactions with Blood, 2017/ ASTM F 756- 17 (Standard Practice for the Assessment of Hemolytic Properties of Materials) | Pass | | In-vitro Hemolysis Test Indirect Method | ISO 10993-04: Biological Evaluation of Medical Devices - Part 04, Selection of Tests for Interactions with Blood, 2017/ ASTM F 756- 17 (Standard Practice for the Assessment of Hemolytic Properties of Materials) | Pass | # **7.3 Electrical safety and electromagnetic compatibility (EMC)** Electrical safety, EMC, device-related electrical safety for high frequency and usability were conducted on the subject device system according to the following consensus standards: - IEC 60601-2-2:2017, Medical electrical equipment - Part 2-2: Particular requirements for the basic safety and essential performance of high frequency surgical equipment and high frequency surgical accessories - IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral Standard: Electromagnetic disturbances – Requirements and Tests Page 10 {14} 510(k) Summary — Potenza Prime K254185 ### 7.4 Bench Testing Jeisys conducted bench testing to assure that the POTENZA operates safely and within the predefined design specifications. Tested parameters included: - Output accuracy (Monopolar at 1MHz and 2 MHz) - Output accuracy (Bipolar at 1MHz and 2MHz) - Frequency: manual and standard - Power fluctuation characteristics - Negative output protection - Impedance measurement accuracy and range - HO count accuracy - Safety test of various warnings / failsafe mechanisms - Needle depth - Motor speed level - Ex Vivo testing conducted on three types of tissue – Liver, Kidney and Muscle under GLP Thermal testing in accordance with FDA’s “Guidance for Industry and FDA Staff: Premarket Notification (510(k)) Submissions for Electrosurgical Devices for General Surgery”, August 15, 2014 ### 7.5 Clinical Studies No clinical performance testing was performed. ### 8. CONCLUSIONS The Potenza Prime is the same as the predicate device with respect to the principles of operation, technological characteristics, as well as performance characteristics. Non-clinical testing was conducted to evaluate the performance of the subject device in comparison to the predicate device. Results of design validation and verification activities, i.e., testing to designated standards and performance testing of the devices, have demonstrated substantial equivalence of the subject device to the predicate in terms of safety and effectiveness for requested intended use. Page 10 of 10