Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)

Q: Who is the manufacturer of Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)?

Agnes Medical Co., Ltd. filed the 510(k) submission for Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A) (K243713).

Q: What is the FDA product code for Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)?

GEI. It is classified under 21 CFR 878.4400 as a Class 2 device in the General, Plastic Surgery panel.

Q: What is the regulatory pathway for Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)?

510(k) clearance (submission type: Traditional).

Q: Who can help prepare an FDA 510(k) submission like Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K243713 · Agnes Medical Co., Ltd. · GEI · Aug 19, 2025 · General, Plastic Surgery

Device Facts

Record ID	K243713
Device Name	Single Use RF Surgical Electrode (Needle Type) (AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A)
Applicant	Agnes Medical Co., Ltd.
Product Code	GEI · General, Plastic Surgery
Decision Date	Aug 19, 2025
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 878.4400
Device Class	Class 2
Attributes	Therapeutic

Intended Use

RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

Device Story

RFMagik is an electrosurgical device delivering radiofrequency (RF) energy for electrocoagulation and hemostasis in dermatologic and general surgical procedures. The system comprises a main console with an LCD interface, a footswitch, and four types of handpieces (RO, AGNES (F) RF, AGNES (B) RF, and VVIP) that utilize disposable micro-needle electrodes. The operator selects modes and parameters via the console panel. RF energy is delivered through the needle electrodes to target tissue; the device operates in monopolar mode at 1MHz. The system is intended for use by healthcare professionals in clinical settings. The output affects tissue via thermal coagulation, facilitating hemostasis. The device is designed to provide controlled RF delivery to achieve desired surgical outcomes.

Clinical Evidence

No clinical data. Evidence consists of bench testing (electrical safety, performance) and ex vivo thermal studies on liver, skin, and muscle tissue conducted under GLP conditions to verify thermal effects.

Technological Characteristics

Monopolar RF electrosurgical device; 1MHz output frequency; max 32W power at 200 ohm. Materials: Stainless steel and dimer C-coated stainless steel needles. Dimensions: 0.2-0.3mm needle thickness; 0.4-5mm insertion depth. Connectivity: Standalone console with LCD. Sterilization: EO gas for disposable tips. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-2, ISO 10993, ISO 11135, ISO 11607.

Indications for Use

Indicated for dermatologic and general surgical procedures requiring electrocoagulation and hemostasis. Prescription use only.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

RFMagik Lite (K242469)

Reference Devices

AGNES (K223805)

Related Devices

K242469 — RFMagik Lite · Agnes Medical Co., Ltd. · Apr 25, 2025
K250217 — AGNES Ultra · Agnes Medical Co., Ltd. · Sep 3, 2025
K192728 — Agnes · Agnes Medical Co., Ltd. · Oct 24, 2019
K203013 — AGNES · Agnes Medical Co., Ltd. · Jul 14, 2022
K223805 — Agnes · Agnes Medical Co., Ltd. · May 4, 2023

Submission Summary (Full Text)

{0} FDA U.S. FOOD & DRUG ADMINISTRATION August 19, 2025 Agnes Medical Co., Ltd % Sanghwa Myung Regulatory Affair Specialist E&m D1474, PyeongCheon Arco Tower, 230, Simin-Daro, Dongan-gu Anyangsi, Gyeonggi 14067 Korea, South Re: K243713 Trade/Device Name: RF Electrosurgical Device (RFMagik) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: July 18, 2025 Received: July 21, 2025 Dear Sanghwa Myung: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K243713 - Sanghwa Myung Page 2 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). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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- {2} K243713 - Sanghwa Myung Page 3 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). Sincerely, JAMES H. JANG -S Digitally signed by JAMES H. JANG -S Date: 2025.08.19 18:17:02 -04'00' James Jang, Ph.D. Acting 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. Submission Number (if known) K243713 Device Name RF Electrosurgical Device (RFMagik) Indications for Use (Describe) RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical 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." {4} K243713 # 510(k) Summary – Traditional 510(K) The assigned 510(k) Number: K243713 01. Date of Submission: July 18, 2025 ## 02. Applicant / Submitter AGNES MEDICAL CO.,LTD #401-402, 24 Dunchon-Daero 388beon-Gil, Jungwon-Gu, Seongnam-Si Gyeonggi, KR 13403 TEL: +82-31-8020-9716 Email: phee3928@agnesmedical.com ## 03. Submission Correspondent Sanghwa Myung E&M. D-1474, 230, Simin-daero, Dongan-gu TEL: +82-70-7807-0550 Email: mshenmc@agnesmedical.com ## 04. Proposed Device Identification ### Device Identification and Regulatory information 1) Proposed Device Identification - Product Name: RF Electrosurgical Device - Trade Name (Model): RFMagik - Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories - Regulation Number: 21 CFR 878.4400 - Device Class: Class II - Product Code: GEI - Review Panel: General & Plastic Surgery 2) Predicate Device Identification - 510(k) Number: K242469 - Product Name: RF Electrosurgical Device - Trade Name (Model): RFMagik Lite - Manufacturer: AGNES MEDICAL CO., LTD. - Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories - Regulation Number: 21 CFR 878.4400 - Device Class: Class II - Product Code: GEI - Review Panel: General & Plastic Surgery {5} K243713 3) Reference Device identification - 510(k) Number: K223805 - Device Name: AGNES - Manufacturer: AGNES MEDICAL CO., LTD. - Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories - Regulation Number: 21 CFR 878.4400 - Device Class: Class II - Product Code: GEI, KCW - Review Panel: General & Plastic Surgery ## 05. Device Description RFMagik is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, two handpieces, single use electrodes, electrode pad, NE pad cable, food switch. There are three handpieces. RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece that delivers RF energy through the disposable electrode in the handpiece. ## 06. Indication for use: RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. ## 07. Summary of Technological Characteristics Comparison 1) Primary Predicate Device | | Subject device | Predicate device | Compassion Comment | | --- | --- | --- | --- | | Manufacturer | AGNES Medical Co., Ltd. | AGNES Medical Co., Ltd. | - | | Device Name | RFMagik | RFMagik Lite | - | | 510(k) number | - | - | - | | Classification Name | Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400) | Electrosurgical cutting and coagulation device and accessories (21 CFR Part 878.4400) | - | | Product code | GEI | GEI | - | | Indication for use | RO handpiece, AGNES (F) RF handpiece and AGNES (B) RF handpiece of RFMagik are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. | RO handpiece and AGNES RF handpiece of RFMagik Lite are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. | Same | {6} K243713 | Handpiece | RO handpiece AGNES (F) RF handpiece AGNES (B) RF handpiece VVIP handpiece | RO handpiece AGNES RF handpiece VVIP handpiece | SE | | --- | --- | --- | --- | | Mode of operation | Monopolar | Monopolar | Same | | Output energy | Radiofrequency | Radiofrequency | Same | | Output Frequency | 1MHz | 1MHz | Same | | Rated Input | AC 100-240V, 50/60Hz | AC 100-240V, 50/60Hz | Same | | Output Power | Max. 32W | Max. 32W | Same | | Maximum Power Delivered to Patient | Up to 32W (200ohm) | Up to 32W (200ohm) | Same | | Impedance | 200 ohm | 200 ohm | Same | | Electrode Needles | 1) Multi needle type RO-25S, RO-25D 2) Needle type GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A, AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A, AN-B4A | 1) Multi needle type RO-25S, RO-25D 2) Needle type GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A | SE | | Electrode type | Micro needle type | Micro needle type | Same | | Electrode needle shelf-life | 3 years | 3 years | Same | | Materials | 1) Multi needle type Stainless Steel 2) Needle type Stainless Steel + dimer C coating | 1) Multi needle type Stainless Steel 2) Needle type Stainless Steel + dimer C coating | Same | | Needle length | 1) Multi needle type 0.4mm, 1.2mm 2) Needle type 0.8 ~ 5mm | 1) Multi needle type 0.4mm, 1.2mm 2) Needle type 0.8 ~ 5mm | Same | | Needle thickness | 1) Multi needle type 0.2 mm 2) Needle type 0.2 ~ 0.3 mm | 1) Multi needle type 0.2 mm 2) Needle type 0.2 ~ 0.25 mm | Different #1 | | Needle amount | 1) Multi needle type 25ea | 1) Multi needle type 25ea | Different #2 | 3 {7} K243713 | | 2) Needle type 1~4ea | 2) Needle type 1~3ea | | | --- | --- | --- | --- | | Needle configuration/layout, | 1) Multi needle type 5X5 (25ea) | 1) Multi needle type 5X5 (25ea) | Same | | Max insertion depth | 1) Multi needle type Max. 1.2mm | 1) Multi needle type Max. 1.2mm | Same | | | 2) Needle type Max. 5mm | 2) Needle type Max. 5mm | | | Min insertion depth | 1) Multi needle type Max. 0.4 | 1) Multi needle type Max. 0.4 | Same | | | 2) Needle type Min. 0.8mm | 2) Needle type Min. 0.8mm | | The subject devices are substantially equivalent to the predicate devices with respect to indications for use, mode of operation, output frequency, output maximum power, RF Intensity, RF Duration, some of electrodes. The basic technology of the subject device and predicate device is the same, but the subject device is equipped with two AGNES RF handpieces found in the predicate device. Along with the added handpiece, the type of Electrode has also been added. Different #1, #2, thickness, amount. The thickness, and number of electrodes of the subject device are the biggest differences from the predicate device. There are some technical differences, which have been demonstrated to be safe and effective in pre-clinical testing. 2) Reference Device | | Subject Device | Reference Device | Comparison Comment | | --- | --- | --- | --- | | Manufacturer | AGNES MEDICAL CO.,LTD | AGNES MEDICAL CO., LTD | - | | Device name | RFMagik | AGNES | - | | 510(k) Number | - | K223805 | - | | Product code / Regulation | GEI 21 CFR 878.4400 | GEI 21 CFR 878.4400 | - | | Classification | Class II | Class II | - | | Indication for use | RFMagik is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis | AGNES is indicated for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. | SAME | {8} K243713 | Prescription or OTC | | Prescription | Prescription | SAME | | --- | --- | --- | --- | --- | | Mode of operation | | Monopolar | Monopolar | SAME | | Waveform | | Oscillating rectangular wave | Oscillating rectangular wave | SAME | | Output frequency | | 1MHz | 1MHz | SAME | | Output operating time | | Min 50ms / Max 2,000ms | Min 50ms / Max 2,000ms | SAME | | Output power levels | | 0~20 levels (0, 2 to 32W) | 25 levels (2 to 46 W) | Different #1 | | Max. output power | | 0, 2 ~ 32W at 200 ohm | 2 ~ 46 W at 200 ohm | Different #2 | | Electrical Safety Standards Complies | | with IEC 60601-1, IEC 60601-1-2, IEC60601-2-2 | with IEC 60601-1, IEC 60601-1-2, IEC60601-2-2 | SAME | | Connected Handpiece | | 1) RO Handpiece 2) AGNES (F) RF Handpiece 3) AGNES (B) RF Handpiece 3) VVIP Handpiece | One Agnes RF handpiece | Different #3 | | Connect patient contact electrode tip | Sterilization | EO gas | EO gas | SAME | | | Shelf Life | 3 Years | 3 Years | SAME | | | FDA Cleared Tip | 1) GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A 2) RO-25S, RO-25D | 1) GA-B, GA-C, GA-E, GA-I, GA-S, GA-W3A, GA-F3A, GA-IL, GA-SL, GA-W3B, GA-F1A 2) AG-CN18G, AG-CN19G, AG-CN20G, AG-CN21G, AG-CN23G | Different #4 | | | New Tips | AN-B, AN-C, AN-E, AN-I, AN-S, AN-W3A, AN-F3A, AN-IL, AN-SL, AN-W3B, AN-F1A, AN-F3B, AN-B3A, AN-B4A | N/A | | | Neutral electrode pad | | 510(k) cleared by FDA | 510(k) cleared by FDA | SAME | | Foot Switch | | Single pedal | Single pedal | SAME | The subject devices are substantially equivalent to the predicate devices with respect to indications for use, mode of operation, output energy type, material, type of sterilization, and shelf life. #1 Output Levels, #2 Max output power The reference device max output power is 46 W and subject device is 32W that subject device is lower {9} K243713 max outpower. The steps of output levels may vary because they are affected by the max output power. In this difference, the maximum power of the subject device is lower than that of the reference device, but since the basic technology is the same, the subject device is within the power range of the reference device. #3, #4 Handpiece type and Electrode tip The reference device has only one handpiece. The subject device has four handpieces. The difference in these handpieces results in different types of electrodes. The tip of the reference device is included in the same handpiece type as the subject device. Any differences between the Subject device and predicate device have no significant influence on safety and effectiveness. Therefore, the subject device is substantially equivalent to the predicate devices. Differences in these characteristics do not in any effect safety and efficacy in evaluating equivalence. There are no significant differences between the Subject device and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics standards. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this # 08. Non-clinical Testing Data ## 1) Biocompatibility The biocompatibility tests were performed in accordance with the FDA recognized standards, - ISO 10993-1:2009, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process. - ISO 10993-5:2009, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity - ISO 10993-10:2021, Biological evaluation of medical devices - Part 10: Tests for skin sensitization - ISO 10993-23:2021 Biological evaluation of medical devices - Part 23: Test for irritation ## 2) Sterility The EO gas sterilization was verified and validated in accordance with the FDA recognized standards - ISO 11135: 2014, Sterilization of health care products - Ethylene oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices - ISO 11138-1:2017, Sterilization of health care products - Biological Indicators - Part 1: General requirements - ISO 11138-2: 2017, Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes - ISO 10993-7: 2008, Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals ## 3) Shelf life - ISO 11607-1: 2019, Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - ISO 11607-2:2019, Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes {10} K243713 ## 4) Performance Testing AGNES MEDICAL conducted bench testing to assure that the operates safely and within the predefined design specifications. ## 5) Ex Vivo Study *Ex Vivo* testing conducted on three types of tissue – Liver, skin 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 ## 09. Clinical Testing Clinical testing is not a requirement and has not been performed. ## 10. Conclusion The comparison between the subject devices and the predicate devices shows that the indication for use and technological characteristic is substantially equivalent although there are some differences, the performance test reports are supported to the substantial equivalence of the subject device, the performance test reports are provided to demonstrate substantial equivalence of the subject devices. Therefore, we conclude that the different characteristics do not raise different questions of safety and effectiveness, and thus the subject devices are substantially equivalent to the predicate devices.