(19 days)
Not Found
No
The device description and other sections do not mention any components or functionalities related to AI, DNN, or ML. It appears to be a medical laser system for varicose vein treatment with user-controlled settings.
Yes
The "Intended Use / Indications for Use" states that Veincare is intended for "treatment of varicose veins and varicosities", clearly indicating a therapeutic purpose.
No
The device description and intended use clearly state that Veincare is for the treatment of varicose veins, not for their diagnosis. It delivers laser energy for therapeutic purposes.
No
The device description clearly outlines hardware components such as a "Laser Diode module, a power supply and a cooling system," as well as delivery mechanisms like an "optical fiber cable" and a "Foot switch." These are physical components, not software-only.
No
Reasoning: The device is a laser system intended for the treatment of varicose veins and not for the in vitro examination of specimens derived from the human body.
N/A
Intended Use / Indications for Use
Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
Product codes
GEX
Device Description
The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470nm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Greater Saphenous Vein, superficial venous system in the lower limb
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/(R)2012 and A1:2012, IEC 60601-1-6 Edition 3.1 2013, IEC 60601-2-22:2007/A:2012, IEC 60825-1 Edition 3.0 2014, IEC 60601-1-2:2014/A1:2020.
Software was designed and developed according to a software development process and was verified and validated.
No clinical studies were considered necessary and performed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
FDA 510(k) Clearance Letter - Veincare Laser System
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID# 04017.07.05
Silver Spring, MD 20993
www.fda.gov
May 14, 2025
Wontech Co., Ltd.
Hyunsik Yoon
Regulatory Affairs Team General Manager
64 Techno 8-ro, Yuseong-gu
Daejeon, 34028
Korea, South
Re: K251288
Trade/Device Name: Veincare
Regulation Number: 21 CFR 878.4810
Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology
Regulatory Class: Class II
Product Code: GEX
Dated: April 25, 2025
Received: April 25, 2025
Dear Hyunsik 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 (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.
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K251288 - Hyunsik Yoon 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-
Page 3
K251288 - Hyunsik Yoon 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,
TANISHA L. HITHE -S
Digitally signed by TANISHA L. HITHE -S
Date: 2025.05.14 14:37:08 -04'00'
Tanisha Hithe
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
Page 4
FORM FDA 3881 (8/23) Page 1 of 1
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): K251288
Device Name: Veincare
Indications for Use (Describe):
Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
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."
Page 5
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 1 / 6
510(k) Summary (K251288)
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
May 9th, 2025
2. Submitter's Information & Contact Person [21 CFR 807.92(a)(1)]
- Name of Manufacturer: WONTECH Co., Ltd.
- Address: 64 Techno 8-ro, Yuseong-gu, Daejeon, 34028, Republic of Korea
- Contact Name: Hyun Sik Yoon
- Telephone No.: +82 42 934 6800
- Fax No.: +82 42 934 9491
- Email Address: regulatory@wtlaser.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
Common name: Surgical Diode Laser System
Trade name: Veincare
| Classification Description | 21 CFR Section | Product Code |
|---|---|---|
| Laser surgical instrument for use in general and plastic surgery and in dermatology | 878.4810 | GEX |
As stated in 21 CFR, parts 878.4810, this generic type of devices has been classified as Class II.
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 1
- 510(k) Number: K241930
- Applicant: WONTECH CO.,LTD.
Page 6
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
- Classification Name: Laser surgical instrument for use in general and plastic surgery and in dermatology
- Trade Name: Veincare
5. Description of the Device [21 CFR 807.92(a)(4)]
The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470nm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy density and enables or disables the laser at the touched LCD panel.
6. Statement of intended use [21 CFR 807.92(a)(5)]
The Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb
7. Summary of Technological Characteristics [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)]
The technical characteristics of subject device are the same as the predicate device. The labeling has been updated and surgical optic fiber has been added as a component. It is substantially equivalent to this device in design, function, and technical characteristic
| Proposed Device | Predicate Device 1 | SE Decision | |
|---|---|---|---|
| K Number | - | K241930 | - |
| Manufacturer | WONTECH Co., Ltd. | WONTECH Co., Ltd. | - |
| Model | Veincare | Veincare | - |
| Intended Use | Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb | Veincare is intended for use in the treatment of varicose veins and varicosities with superficial reflux of the Greater Saphenous Vein, and in the treatment of incompetent refluxing veins in the superficial venous system in the lower limb | Same as #1 |
| Principle/Method of Operation | The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470nm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy | The Veincare laser system consists of a Laser Diode module, a power supply and a cooling system. The laser diode module consists of an optical sensor interface, fiber connector for high power SMA fiber, protective glass holder, monitoring interface, cathode and anode. The system delivers laser energy at a wavelength of 1470nm. The output of the laser is delivered to the area of treatment through an optical fiber cable a trigger (Foot switch) controls the delivery of pulses. The user selects the desired energy | Same as #1 |
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64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 5 / 5
| Proposed Device | Predicate Device 1 | SE Decision | |
|---|---|---|---|
| density and enables or disables the laser at the touched LCD panel. | density and enables or disables the laser at the touched LCD panel. | ||
| Maximum Power Output | 0.5~15W | 0.5~15W | Same as #1 |
| Wavelength | 1470nm | 1470nm | Same as #1 |
| Pulse Repetition | 1Hz ~ 500Hz | 1Hz ~ 500Hz | Same as #1 |
| Pulse duration | 0.2ms ~ 800ms | 0.2ms ~ 800ms | Same as #1 |
| Mode of Operation | CW, pulsed, Group pulsed | CW, pulsed, Group pulsed | Same as #1 |
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:
- IEC 60601-1:2005/(R)2012 and A1:2012 Medical electrical equipment - Part 1: General requirements for basic safety
- IEC 60601-1-6 Edition 3.1 2013 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance
- IEC 60601-2-22:2007/A:2012 Medical electrical equipment – Part 2-22: Particular requirements for basic safety and essential performance
- IEC 60825-1 Edition 3.0 2014 Safety of laser products - Part 1: Equipment classification, and requirements
- IEC 60601-1-2:2014/A1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential perform
2) Software Validation
The Veincare 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
Page 8
64 Techno 8-ro, Yuseong-gu, Daejeon, Republic of Korea
TEL: +82 (42) 934 6800 FAX: +82 (42) 934 9491
Page 5 / 5
- The part of the device that comes into contact with the human body is the optical fiber. However, the optical fiber that is a component of the device has received 510(k) clearance beforehand (K232106 and K241643). Therefore, no additional biocompatibility test report is needed.
4) Performance Testing
The performance of the Veincare has been defined as follows.
- Laser wavelength: 1470nm
- Laser output power: 0.5 to 15 W
- Pulse /duration:
- Pulse mode: (0.2 to 800)ms
- Group pulse mode: (0.2 to 800)ms
- CW mode: CW
- Pulse frequency: 1-500Hz
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 WONTECH Co., Ltd. concludes that the Veincare is substantially equivalent to the predicate device as described herein.