(32 days)
Not Found
No
The summary describes a radio frequency therapy system with standard components and functionalities for electrocoagulation and hemostasis. There is no mention of AI, ML, image processing, or any data-driven decision-making processes within the device description or performance studies.
Yes
The device is intended for non-invasive electrocoagulation and hemostasis of soft tissue, which are therapeutic procedures.
No
The device is used for electrocoagulation and hemostasis of soft tissue, which are therapeutic procedures, not diagnostic ones. It delivers radio frequency energy to non-invasively treat tissue.
No
The device description explicitly lists multiple hardware components including a main body, RF handpiece, return pads, cables, tips, cooling fluids, footswitch, and power cable, indicating it is a physical device with software control, not a software-only device.
Based on the provided information, the 'Oligio X' device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "non-invasive electrocoagulation and hemostasis of soft tissue" in dermatologic and general surgical procedures. This describes a therapeutic procedure performed directly on the patient's body, not a test performed on a sample taken from the body.
- Device Description: The description details a radio frequency therapy system that delivers energy to the patient's tissue. This is consistent with a therapeutic device, not a diagnostic device that analyzes samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), performing tests on these samples, or providing diagnostic information based on such analysis.
Therefore, the 'Oligio X' is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The 'Oligio X' is intended for use in dermatologic and general surgical procedures for non-invasive electrocoagulation and hemostasis of soft tissue.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and soft tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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: IEC 60601-1:2005, AMD1:2012, IEC 60601-2-2:2017, IEC 60601-1-2:2014, IEC 61000-3-2:2018.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.
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)
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.
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Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
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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 | ||
| Accessories | 878.4400 | GEI |
As stated in 21 CFR, parts 878.4400, this generic types of devices has been classified as Class II.
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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.
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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 | ||
| procedures for non-invasive | |||
| electrocoagulation and hemostasis | |||
| of soft tissue | Dermatologic and general surgical | ||
| procedures for non-invasive | |||
| electrocoagulation and hemostasis | |||
| of soft tissue | Same | ||
| Anatomical site | Skin and soft tissue | Skin and soft tissue | Same |
| Principle/Method of | |||
| Operation | '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. | '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. | Same | ||
| Output frequency | 6.78MHz±1% | 6.78MHz±1% | Same |
| Max output power | 140 W | 145 W | Different |
| The Device | |||
| Max | |||
| output | |||
| power has been | |||
| changed into | |||
| 140 W, due to | |||
| the marketing | |||
| strategy of the | |||
| 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 | |||
| (Main | |||
| 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 | |
| has | |||
| been | |||
| changed into | |||
| 479mm width, | |||
| due to the | |||
| marketing | |||
| strategy of the | |||
| manufacturer. | |||
| Appearance of Main | |||
| Unit | Image: Main unit front and back | Image: Main unit front and back | Different |
| The Return pad | |||
| has | |||
| been | |||
| changed into | |||
| back position | |||
| and Foot Switch | |||
| cable | |||
| connection | |||
| position has | |||
| been added, due | |||
| to the marketing | |||
| strategy of the | |||
| manufacturer. | |||
| Accessories | |||
| of | |||
| Return Cable | Image: Return cable, Size: 3.0m, with labels 2, 3, 4 | Image: Return cable, Size: 1.7m | Different |
| The | |||
| Return | |||
| Cable has been | |||
| changed into | |||
| longer, due to | |||
| the marketing | |||
| strategy of the | |||
| manufacturer. | |||
| Accessories of Foot | |||
| Switch | Image: Foot switch | - | Different |
| The | |||
| Foot | |||
| Switch has been | |||
| added new, due | |||
| to the marketing | |||
| strategy of the | |||
| manufacturer. | |||
| Accessories | |||
| of | |||
| Cooling gas | Image: Two white cans, one with a black top and one with a white top | ||
| (R-134a) (R-1234ZE) | Image: White can with red and black text | Different | |
| The Cooling | |||
| gas has been | |||
| added new, due | |||
| to the marketing | |||
| strategy of the | |||
| manufacturer. | |||
| Accessories | |||
| of | |||
| Coupling fluid | Image: Transparent tube with orange liquid | Image: White tube with purple text | Different |
| The Coupling | |||
| fluid has been | |||
| changed tube | |||
| design, due to | |||
| the marketing | |||
| strategy of the | |||
| manufacturer. | |||
| GUI Design | Image: GUI design with red arrow | Image: GUI design | Different |
| The GUI has | |||
| been changed, | |||
| due to the | |||
| marketing | |||
| strategy of the | |||
| manufacturer. | |||
| Electrical Design |
SystemBlockDiagram | Image: Electrical design diagram | Image: Electrical design diagram | Different
The
SystemBlockDiagram has been
changed, due to
the marketing
strategy of the
manufacturer. |
7
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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.
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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".
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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
| (Edition) | Standard Title |
|---|---|
| IEC 60601-1:2005, | |
| AMD1:2012 | Amendment 1 - Medical electrical equipment - Part 1: General |
| requirements for basic safety and essential performance | |
| IEC 60601-2-2:2017 for use in | |
| conjunction with IEC 60601- | |
| 1:2005, IEC 60601- | |
| 1:2005/AMD1:2012 | 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 | |
| IEC 61000-3-2:2018 | Electromagnetic compatibility (EMC) - Part 3-2: Limits - Limits for |
| 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
Contact | Duration of Contact
by ISO 10993-1 | Bio-
compatibility |
|--------|-------------------------------|--------------------|---------------------------------------|-----------------------|
| RF tip | Polyethylene
terephthalate | Intact Skin | Limited
(