Ellian Enigma RF Device

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 2, 2026 Ellian Corp Julie Summerville CEO 1825 E. Plano Pkwy. Suite 200 Plano, Texas 75074 Re: K262364 Trade/Device Name: Ellian Enigma RF Device Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 10, 2026 Received: July 10, 2026 Dear Julie Summerville: 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" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262364 - Julie Summerville Page 2 (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). 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} K262364 - Julie Summerville Page 3 Sincerely, Colin K. Chen Digitally signed by Colin K. Chen -S Date: 2026.09.02 07:45:10 -04'00' -S Colin K. Chen 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) K262364 Device Name Enigma RF Device Indications for Use (Describe) The Enigma RF Device is intended for use in dermatologic procedures for electrocoagulation and hemostasis. 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} # K262364 # 510(k) SUMMARY # Ellian Enigma RF Device Prepared in accordance with the requirements of 21 CFR 807.92 A. SPONSOR INFORMATION | Item | Information | | --- | --- | | Submitter | Ellian Corp 1825 E. Plano Parkway, Suite 200 Plano, TX 75074, USA | | Contact Person | Julie Summerville | | Telephone | (972) 380-2911 | | Email | jsummerville@ellianmed.com | | Date Prepared | September 1st, 2026 | B. DEVICE NAME | Item | Information | | --- | --- | | Trade / Proprietary Name | Enigma RF Device | | Common / Usual Name | Electrosurgical device | | Classification Name | Electrosurgical cutting and coagulation device and accessories | | Regulation Number | 21 CFR 878.4400 | | Regulatory Class | Class II | | Product Code | GEI | | Review Panel | General and Plastic Surgery | | Predicate Device | VIVACE Electrosurgical System, ShenB Co., Ltd. K193070 | # C. INTENDED USE / INDICATIONS FOR USE The Enigma RF Device is intended for use in dermatologic procedures for electrocoagulation and hemostasis. # D. DEVICE DESCRIPTION The Enigma RF Device is a radiofrequency output device that delivers bipolar radiofrequency energy at 1 MHz to the human body through a disposable needle cartridge attached to a handheld, battery-powered pen-style handpiece. The system consists of a single handpiece with an integrated touch display, one type of single-patient-use disposable cartridge containing 36 insulated microneedle electrodes and a charging base. # E. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS {5} The subject Enigma RF Device and the predicate VIVACE Electrosurgical System (K193070) share the same intended use, the same regulatory classification and product codes, and the same fundamental scientific technology. The tables below compare the two devices. **Table 1. Device Identification** | | Subject Device | Predicate Device | | --- | --- | --- | | **510(k) Number** | K262364 | K193070 | | **Device Name** | Enigma RF Device | VIVACE Electrosurgical System | | **Manufacturer** | Ellian 1825 E. Plano Parkway, Suite 200 Plano, TX 75074, USA | ShenB Co., Ltd. Shenb Bldg, 148 Seongsui-ro, Seongdong-Gu Seoul, KR 04796 | | **Classification / Product Code** | 21 CFR 878.4400 / GEI | 21 CFR 878.4400 / GEI | | **Regulatory Class** | Class II | Class II | **Table 2. Indications for Use Comparison** | | Subject Device Enigma RF Device | Predicate Device VIVACE (K193070) | Comparison | | --- | --- | --- | --- | | **Indications for Use** | The Enigma RF Device is intended for use in dermatologic procedures for electrocoagulation and hemostasis. | The VIVACE Electrosurgical System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis and the percutaneous treatment of facial wrinkles for use with Fitzpatrick Skin Type I to Skin Type V when using the 1 MHz setting. | The predicate device is indicated for the treatment of wrinkles; the subject device's indications for use do not include wrinkle treatment. Treatment for the supported indications is appropriate for all skin types. | **Table 3. Comparison of Technological Characteristics** | Specification | Subject Device Enigma RF Device | Predicate Device VIVACE (K193070) | Comparison | | --- | --- | --- | --- | | **Source of Energy** | Bipolar RF | Bipolar Fractional RF | Same | | **Delivery System** | Bipolar handpiece + microneedle electrodes | Bipolar handpiece + microneedle electrodes | Same | | **RF Frequency** | 1 MHz (±10%) | 1 MHz (±10%), 2 MHz (±10%) | The 1 MHz function is the same for both devices. The subject device does not include a 2 MHz setting. | {6} | Specification | Subject Device Enigma RF Device | Predicate Device VIVACE (K193070) | Comparison | | --- | --- | --- | --- | | Maximum Power | 17 W (load resistance 500 Ω) | 1 MHz: 36 W (load resistance 500 Ω) 2 MHz: 23.3 W (load resistance 500 Ω) | The maximum power of the subject device is lower than that of the predicate device. Comparative thermal and histopathological bench testing demonstrates equivalent performance. | | Connected Electrodes | 36 electrodes | 36 electrodes | Same | | Electrode Array | 36 each, 6 × 6 array | 36 each, 6 × 6 array | Same | | Needle Outer Diameter | Ø 0.3 mm | Ø 0.3 mm | Same | | Needle Insert Depth | 0.5 – 3.5 mm (0.25 mm step, 13 settings) | 0.5 – 3.5 mm (0.1 mm step) | Same treatment depth range. | | Intensity | 1–10 Level (1 Step) | 1–10 Level (1 Step) | Same | | User Interface | Integrated touch display on handpiece | LCD touch screen control panel | Same function; different implementation. See discussion | | Electrical Requirements | 100–240 VAC, 50/60 Hz (charging base) Internal rechargeable battery, 14.8 V DC | 120 VAC, 50/60 Hz | Different. The subject device is battery powered with a charging base while the predicate is mains powered. | | Weight | 331g | 24 kg (without arm) | Different. | | Dimensions | Pen with cartridge: 200mm (L) x 46mm (W) x 56mm (D) | (W) 380 mm × (L) 340 mm × (H) 1200 mm | Different. | ### F. PERFORMANCE DATA The following non-clinical performance testing was conducted to support a determination of substantial equivalence: - Electrical safety and essential performance testing in accordance with - ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021] - IEC 60601-2-2 Edition 6.0 2017-03 - IEC 60601-1-2:2014 [Including AMD 1:2021] - IEC TS 60601-4-2 Edition 1.0 2024-03 {7} - Biocompatibility evaluation of patient-contacting components in accordance with ISO 10993-1 Fifth edition 2018-08 - Sterilization and packaging validation for the single-use needle cartridge was performed in accordance with • ISO 11607-1 Second edition 2019-02 • ISO 11737-1 Third edition 2018-01 [Including AMD1:2021] - Software verification and validation testing in accordance with IEC 62304:2006 - Software life cycle processes and FDA Guidance on Premarket Submissions for Device Software Functions (Enhanced Level Documentation) - Risk Management is conducted in accordance with ISO 14971, third edition 2019-12 - Thermal and histopathological performance testing in accordance with FDA Guidance on Electrosurgical Devices ### G. SUMMARY OF SUBSTANTIAL EQUIVALENCE The Enigma RF Device has the same intended use as the predicate VIVACE Electrosurgical System (K193070) and is regulated under the same classification regulation and product codes. Both devices deliver bipolar radiofrequency energy at 1 MHz through a bipolar handpiece and an array of 36 microneedle electrodes arranged in a \( 6 \times 6 \) configuration, inserted percutaneously to a depth within the range of 0.5 mm to 3.5 mm, with treatment intensity selectable over 10 levels. The fundamental scientific technology and the mechanism by which the clinical effect is achieved are therefore identical. The differences in technological characteristics identified in Table 3 are addressed below. #### Maximum power The maximum output power of the subject device, measured into the same 500 Ω load resistance used to characterize the predicate, is lower than that of the predicate device. A lower maximum output does not introduce a new risk relative to the predicate. Comparative bench testing demonstrated that, at matched operating settings, the subject device produces thermal distributions and micro-coagulation zone dimensions comparable to those of the predicate, confirming equivalent tissue effect. #### Electrical requirements and user interface. The predicate device is a mains-powered console with a tethered handpiece and a console-mounted LCD touch screen control panel. The subject device is a self-contained, battery-powered handpiece with an integrated touch display and a charging base. Both devices provide the same operator control functions, namely selection of insertion depth and intensity and initiation of radiofrequency delivery. The tissue interaction at the needle-electrode interface is determined by the radiofrequency output characteristics and the electrode geometry, which are equivalent, and is not affected by the physical location of the radiofrequency generator or of the display. ### I. CONCLUSION The Enigma RF Device has the same intended use and the same fundamental scientific technology as the predicate VIVACE Electrosurgical System (K193070). Where differences in technological characteristics exist, they represent simplifications of, or reductions relative to, the capabilities of the predicate device, and each has been shown not to raise new questions of safety or effectiveness. Based on the comparison of intended use, technological characteristics and performance data presented, the Ellian Enigma RF Device is substantially equivalent to the predicate VIVACE Electrosurgical System (K193070).