Oligio X

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. January 21, 2025 WON TECH Co., Ltd. Hyun Sik Yoon General Manager 64 Techno8-ro, Yuseong-gu Daejeon, 34028 Korea, South ### Re: K243929 Trade/Device Name: Oligio X Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 18, 2024 Received: December 20, 2024 ### Dear Hyun Sik Yoon: 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 (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. {1}------------------------------------------------ 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 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-reportingcombination-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-device-advicecomprehensive-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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatory {2}------------------------------------------------ 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, Digitally signed by Long H. Chen Long H. Chen -S-s Date: 2025.01.21 11:19:32 -05'00' Long 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}------------------------------------------------ # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K243929 Device Name Oligio X Indications for Use (Describe) The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue. 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}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the text 'K243929' in a clear, sans-serif font. The characters are well-defined and evenly spaced. The text appears to be a code or identifier, possibly a serial number or product key. Image /page/4/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside of it, followed by the text "WONTECH". The "WON" part of the text is orange, while the "TECH" part is gray. The logo is simple and modern, and the colors are eye-catching. # 510(k) Summary [As required by 21 CFR 807.92] #### 1. Date Prepared [21 CFR 807.92(a)(a)] 2024.12.20 #### 2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] - Name of Manufacturer: WON TECH Co., Ltd. - Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea - Contact Name: Hyun Sik Yoon - Telephone No.: +82-10-6750-5346 - Fax No.: +82-70-7836-0110 - Email Address: yoonhs21@wtlaser.com #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)| Common name: Radio Frequency Therapy System Trade name: Oligio X | Classification Description | 21 CFR Section | Product Code | |-------------------------------------------------------------------|----------------|--------------| | Electrosurgical Cutting and Coagulation Device and<br>Accessories | 878.4400 | GEI | As stated in 21 CFR, parts 878.4400, this generic types of devices has been classified as Class II. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with two white curved lines inside, resembling a stylized "W". To the right of the circle, the word "WONTECH" is written in a combination of orange and gray. The "WON" part of the word is in orange, while the "TECH" part is in gray. #### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)| The identified predicate devices within this submission are shown as follow: Predicate device - 510(k) Number: K240313 - Applicant: WON TECH Co., Ltd. ● - Classification Name: Electrosurgical Cutting and Coagulation Device and Accessories - . Trade Name: Oligio X #### Description of the Device [21 CFR 807.92(a)(4)] ട്. Oligio X is a radio frequency therapy system. The radio frequency output of the device is 6.78 MHz, and the maximum power is 200 W. Oligio X consists of a main body including touch LCD monitor, a RF handpiece, return pads, a return pad cable, non-sterile treatment tips, cooling fluids, footswitch and a power cable. Oligio X RF System delivers radio frequency energy for selective coagulation of tissue while conductively cooling the epidermis. Oligio X delivers energy form the disposable tip to the patient, and employs radio frequency turning to provide radio frequency energy across a range of impedances for delivery to the patient through the tip. #### Indications for Use [21 CFR 807.92(a)(5)] 6. Oligio X is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue. {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized white "W" inside of it. To the right of the circle is the text "WONTECH" in a sans-serif font. The "WON" part of the text is orange, while the "TECH" part is gray. 64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491 #### Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)] 7. There are no significant differences between Oligio X 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. | | Proposed Device | Predicate Device | SE Decision | |----------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | K Number | | K240313 | - | | Manufacturer | WON TECH Co., Ltd. | WON TECH Co., Ltd | - | | Model | Oligio X | The Olgio | - | | Intended Use | Dermatologic and general surgical<br>procedures for non-invasive<br>electrocoagulation and hemostasis<br>of soft tissue | Dermatologic and general surgical<br>procedures for non-invasive<br>electrocoagulation and hemostasis<br>of soft tissue | Same | | Anatomical site | Skin and soft tissue | Skin and soft tissue | Same | | Principle/Method of<br>Operation | 'Oligio X' RF System delivers radio<br>frequency energy for selective<br>coagulation of tissue while<br>conductively cooling the epidermis.<br>'Oligio X' delivers energy form the<br>disposable tip to the patient, and<br>employs radio frequency turning to<br>provide radio frequency energy<br>across a range of impedances for<br>delivery to the patient through the<br>tip. | 'Oligio X' RF System delivers radio<br>frequency energy for selective<br>coagulation of tissue while<br>conductively cooling the epidermis.<br>'Oligio X' delivers energy form the<br>disposable tip to the patient, and<br>employs radio frequency turning to<br>provide radio frequency energy<br>across a range of impedances for<br>delivery to the patient through the<br>tip. | Same | | Output frequency | 6.78MHz±1% | 6.78MHz±1% | Same | | Max output power | 140 W | 145 W | Different<br>The Device<br>Max<br>output<br>power has been<br>changed into<br>140 W, due to<br>the marketing<br>strategy of the<br>manufacturer. | | Dimension of RF tip | 0.25, 4.0 cm² | 0.25, 4.0 cm² | Same | | Mode of Operation | Manual or footswitch | Manual or footswitch | Same | | Dimensions<br>(Main<br>body) | 479 mm(W) x 490 mm(D) | 580 mm(W) x 490 mm(D) | Different | | | x 1210 mm(H) | x 1210 mm(H) | The Dimensions<br>has<br>been<br>changed into<br>479mm width,<br>due to the<br>marketing<br>strategy of the<br>manufacturer. | | Appearance of Main<br>Unit | Image: Main unit front and back | Image: Main unit front and back | Different<br>The Return pad<br>has<br>been<br>changed into<br>back position<br>and Foot Switch<br>cable<br>connection<br>position has<br>been added, due<br>to the marketing<br>strategy of the<br>manufacturer. | | Accessories<br>of<br>Return Cable | Image: Return cable, Size: 3.0m, with labels 2, 3, 4 | Image: Return cable, Size: 1.7m | Different<br>The<br>Return<br>Cable has been<br>changed into<br>longer, due to<br>the marketing<br>strategy of the<br>manufacturer. | | Accessories of Foot<br>Switch | Image: Foot switch | - | Different<br>The<br>Foot<br>Switch has been<br>added new, due<br>to the marketing<br>strategy of the<br>manufacturer. | | Accessories<br>of<br>Cooling gas | Image: Two white cans, one with a black top and one with a white top<br>(R-134a) (R-1234ZE) | Image: White can with red and black text | Different<br>The Cooling<br>gas has been<br>added new, due<br>to the marketing<br>strategy of the<br>manufacturer. | | Accessories<br>of<br>Coupling fluid | Image: Transparent tube with orange liquid | Image: White tube with purple text | Different<br>The Coupling<br>fluid has been<br>changed tube<br>design, due to<br>the marketing<br>strategy of the<br>manufacturer. | | GUI Design | Image: GUI design with red arrow | Image: GUI design | Different<br>The GUI has<br>been changed,<br>due to the<br>marketing<br>strategy of the<br>manufacturer. | | Electrical Design<br>-<br>SystemBlockDiagram | Image: Electrical design diagram | Image: Electrical design diagram | Different<br>The<br>SystemBlockDiagram has been<br>changed, due to<br>the marketing<br>strategy of the<br>manufacturer. | {7}------------------------------------------------ {8}------------------------------------------------ Image /page/8/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circular icon with a stylized "W" inside, followed by the text "WONTECH" in a combination of orange and gray. The "WON" portion of the text is in orange, while "TECH" is in gray. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH" in orange and gray. The "WON" part of the text is in orange, while the "TECH" part is in gray. Image /page/9/Figure/3 description: The image is divided into three sections. The first section contains the title "Electrical Design - InsulationDiagram". The second section contains two electrical diagrams. The third section contains the text "The InsulationDiagram has been changed, due to the marketing strategy of the manufacturer". {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" portion of the text is orange, while the "TECH" portion is gray. ### Non-Clinical Test Summary [21 CFR 807.92(b)(1)] ### 1) Electrical Safety, Electromagnetic Compatibility Testing Bench tests were conducted to verify that the proposed device met all design specifications. The test results demonstrated that the proposed device complies with the following standards: | Standard<br>(Edition) | Standard Title | |--------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | IEC 60601-1:2005,<br>AMD1:2012 | Amendment 1 - Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential performance | | IEC 60601-2-2:2017 for use in<br>conjunction with IEC 60601-<br>1:2005, IEC 60601-<br>1:2005/AMD1:2012 | Medical electrical equipment - Part 2-2: Particular requirements for the<br>basic safety and essential performance of high frequency surgical<br>equipment and high frequency surgical accessories | | IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic<br>safety and essential performance - Collateral Standard: Electromagnetic<br>disturbances - Requirements and tests | | IEC 61000-3-2:2018 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for<br>harmonic current emissions (equipment input current ≤16 A per phase) | ### 2) Software Validation Oligio X contains MODERATE level of concern software. Software was designed and developed according to a software development process and was verified and validated. The software information is provided in accordance with FDA guidance: The content of premarket submissions for software contained in medical devices, on May 11, 2005. ### 3) Biocompatibility | Part | Material | Patient<br>Contact | Duration of Contact<br>by ISO 10993-1 | Bio-<br>compatibility | |--------|-------------------------------|--------------------|---------------------------------------|-----------------------| | RF tip | Polyethylene<br>terephthalate | Intact Skin | Limited<br>(< 24 hours) | Yes | ### 4) Performance Testing The performance of Oligio X has been defined as follows. - RF output frequency: 6.78MHz ± 1% - - -Max output power: 140 W - Handpiece vibration: Low (30dB), Medium (40dB), High (50dB) - {11}------------------------------------------------ Image /page/11/Picture/1 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the text "WONTECH" in a sans-serif font. The "WON" part of the text is orange, while the "TECH" part is gray. ### Clinical Test Summary [21 CFR 807.92(b)(2)] No clinical studies were considered necessary and performed. ### Conclusion [21 CFR 807.92(b)(3)] In according with the Federal Food & drug and cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification WON TECH Co., Ltd. concludes that Oligio X is substantially equivalent to predicate devices as described herein.