(136 days)
No
The device description focuses on the hardware components and user-controlled settings, with no mention of AI, ML, or image processing.
Yes
The device is intended for the treatment of medical conditions (varicose veins and varicosities), and it uses laser energy to achieve this therapeutic effect.
No
The device is described as treating varicose veins and delivering laser energy for treatment, not for diagnosing conditions.
No
The device description clearly outlines hardware components including a Laser Diode module, power supply, cooling system, optical sensor interface, fiber connector, protective glass holder, monitoring interface, cathode, anode, optical fiber cable, and a foot switch. This indicates it is a hardware-based medical device with a software interface (LCD panel).
Based on the provided information, the Veincare device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Veincare is for the treatment of varicose veins and incompetent refluxing veins. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details a laser system designed to deliver energy to tissue. This is consistent with a therapeutic device used for ablation or treatment, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. Veincare is used in vivo (inside the body) for treatment.
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
The Veincare is intended for use in the treatment of varicosties 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 (comma separated list FDA assigned to the subject device)
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 1470mm. 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
Prescription Use (Part 21 CFR 801 Subpart D)
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)
Non-Clinical Test Summary:
- 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, IEC 60601-1-6 Edition 3.1 2013, IEC 60601-2-22:2007/A:2012, IEC 60825-1 Edition 3.0 2014, and IEC 60601-1-2:2014/A1:2020.
- Software Validation: The Veincare contains MODERATE level of concern software was designed and developed according to a software development process and was verified and validated.
- Biocompatibility: No additional biocompatibility test report is needed as the optical fiber component has received 510(k) clearance beforehand (e.g., K232106).
- Performance Testing: The performance of the Veincare has been defined as 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:
No clinical studies were considered necessary and performed.
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.
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
§ 878.4810 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.
0
November 14, 2024
Image /page/0/Picture/1 description: The image shows 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 square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Wontech Co., Ltd. Hyunsik Yoon Regulatory Affairs Team General Manager 64 Techno 8-Ro, Yuseong-Gu Daejeon, 34028 Korea. South
Re: K241930
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: July 1, 2024 Received: July 1, 2024
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/cdrb/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 OS 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 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 mediation-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).
2
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/deviceadvice-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).
Sincerely,
TANISHA L.
HITHE -S
FD
Digitally signed by TANISHA
L. HITHE-S
Date: 2024.11.14 21:45:34
-05'00'
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
3
Indications for Use
510(k) Number (if known) K241930
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)
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4
Image /page/4/Picture/0 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". The "WON" part of the text is orange, while the "TECH" part is gray.
510(k) Summary (K241930)
[As required by 21 CFR 807.92]
1. Date Prepared [21 CFR 807.92(a)(a)]
November 6, 2024
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 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: | K181632 |
|---|---|
| • Applicant: | Quanta System Spa |
5
Image /page/5/Picture/0 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". 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 Classification Name: Laser surgical instrument for use in general and plastic surgery and ● in dermatology
- Trade Name: VenaCure 1470 Pro ●
Predicate device 2
| • 510(k) Number: | K160549 |
|---|---|
| • Applicant: | Wuhan Gigaa Optronics Technology Co., Ltd. |
| • Classification Name: | |
| in dermatology | Laser surgical instrument for use in general and plastic surgery and |
| • Trade Name: | VELASII-15D |
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 1470mm. 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.
Statement of intended use [21 CFR 807.92(a)(5)] 6.
The Veincare is intended for use in the treatment of varicosties 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)]
There are no significant differences between the Veincare 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 1 | Predicate Device 2 | SE Decision | |
|---|---|---|---|---|
| K Number | - | K181632 | K160549 | - |
| Manufactu | ||||
| rer | WON TECH Co., Ltd. | Quanta System Spa | Wuhan Gigga Optronics | |
| Technology Co., Ltd. | - | |||
| Model | Veincare | VenaCure 1470 Pro | Medical Diode Laser System | - |
| Intended | ||||
| Use | Veincare is intended for use in | |||
| the treatment of varicose veins | ||||
| and varicosities with superficial | ||||
| reflux of the Greater Saphenous | intended for use in the treatment of | |||
| varicose veins and varicosities with | ||||
| superficial reflux of the Greater | ||||
| Saphenous Vein, and in the | Indicated for the treatment of | |||
| reflux of the saphenous veins | ||||
| associated with varicose veins | ||||
| and varicosities | Same as 1, | |||
| similar to 2 |
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Image /page/6/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circle with a stylized "W" inside, followed by the word "WON" in orange and "TECH" in gray. The "W" in the circle is made up of three curved lines that resemble flames.
| Proposed Device | Predicate Device 1 | Predicate Device 2 | SE Decision | |
|---|---|---|---|---|
| Vein, and in the treatment of | ||||
| incompetent refluxing veins in | ||||
| the superficial venous system in | ||||
| the lower limb | treatment of incompetent refluxing | |||
| veins in the superficial venous | ||||
| system in the lower limb | ||||
| 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 density and enables or | ||||
| disables the laser at the touched | ||||
| LCD panel. | The VenaCure 1470 Pro is a diode | |||
| laser system emitting at 1470 nm | ||||
| wavelength, with maximum output | ||||
| power 15 W. Only the use of | ||||
| optical fibers manufactured by | ||||
| AngioDynamics (provided with | ||||
| RFID tag with proprietary internal | ||||
| code) is allowed with the Any | ||||
| other use is forbidden. | ||||
| The front panel of the device | ||||
| includes the touch screen display, | ||||
| the optical fiber connector (SMA |
- with the RFID antenna, the
external protection shutter and the
sliding knob. On the rear panel the
footswitch connector, the key
switch, the remote interlock and
the main switch are located. The
emergency stop button is on the
upper part of the device | The medical diode laser
systems for this unit is GaAlAs
diode bar, and the wavelength
is 1470nm of VELASII-15D. It
features impact structure, high
efficiency and long lifetime.
The beam divergence angle is
too large lead to poor beam
quality. In order to better meet
the needs of Laser Diode
practical applications, Laser
Diode carried beam shaping is
very necessary. With the
GIGAA'S unique fiber-
coupling technology, the laser
beam can be coupled
efficiently into the fiber. | Same as 1
and 2 |
| Maximum
Power
Output | 0.515W | 15W | 115W | Same as 1
and 2 |
| Wavelengt
h | 1470nm | 1470nm | 1470nm | Same as 1
and 2 |
| Pulse
Repetition | 1Hz~500Hz | Up to 2000Hz | 0.2 Hz ~ 50Hz | Similar to 1
and 2, does
not affect
safety and
efficacy |
| Pulse
duration | 0.2ms ~ 800ms | Up to 10,000ms | 10ms ~ 2500ms | Similar to 2,
does not
affect safety
and efficacy |
| Mode of
Operation | CW, pulsed, Group pulsed | CW, pulsed | CW, single pulse, repeat pulse | Same as 1
and 2 |
7
Image /page/7/Picture/0 description: The image shows the logo for WONTECH. The logo consists of an orange circular graphic with a stylized "W" inside, followed by the text "WONTECH". The "WON" part of the text is in orange, while the "TECH" part is in gray.
Non-Clinical Test Summary [21 CFR 807.92(b)(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
Medical electrical equipment - Part 2-22: Particular requirements for basic • IEC 60601-2-22:2007/A:2012 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 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.
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Image /page/8/Picture/0 description: The image shows the Wontech logo. The logo consists of an orange circular icon with a stylized "W" inside, followed by the word "WONTECH". The "WON" part of the word is in orange, while the "TECH" part is in gray.
3) Biocompatibility
- 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 (e.g., K232106). Therefore, no additional biocompatibility test report is needed.
-
- 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 WON TECH Co., Ltd. concludes that the Veincare is substantially equivalent to predicate devices as described herein.