Identity
- Trade Name
- Veincare FDA UDI
- Generic Name
- General/multiple surgical diode laser system FDA UDI
- Device Name
- Surgical Diode Laser System FDA UDI
- Model / Reference
- Veincare FDA UDI
- Description
- Surgical Diode Laser System FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800022301404 FDA UDI
- FDA Product Code
- GEX FDA 510(k)FDA UDI
- GMDN Term
- General/multiple surgical diode laser system FDA UDI
Classification
- Device Class
- Class II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4810 FDA 510(k)
- Regulation Number
- 878.4810 FDA 510(k)FDA UDI
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Contains Latex
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The Veincare Vein Treatment System is a medical device classified under the product code GEX, designed for the treatment of venous conditions. It is intended for procedures related to general and plastic surgery, specifically targeting the removal or ablation of varicose veins and related vascular issues through minimally invasive techniques.
This system is supplied sterile for single-use applications and is intended for use in clinical settings by trained medical professionals. The device is regulated under FDA 510(k) clearance (K241930) and is substantially equivalent to a predicate device, adhering to traditional review standards. Storage and handling must comply with sterile medical device protocols to ensure safety and efficacy.
Frequently asked questions
What types of venous conditions is the Veincare Vein Treatment System designed to address, and how does it work?
The Veincare Vein Treatment System is specifically designed for minimally invasive procedures targeting varicose veins and related vascular issues. It works through techniques that allow for the removal or ablation of affected veins, helping to alleviate symptoms like swelling, pain, and cosmetic concerns. This system is intended for use in clinical settings by trained professionals in general and plastic surgery.
Is the Veincare Vein Treatment System reusable, or is it meant for single-use only?
The Veincare Vein Treatment System is supplied sterile and intended for single-use only. This ensures patient safety and maintains sterility standards, as reuse could compromise the device’s integrity and introduce infection risks. Always follow sterile medical device protocols for storage and handling.
How should the Veincare Vein Treatment System be stored to maintain its sterility and functionality?
Since the Veincare Vein Treatment System is sterile upon delivery and designed for single-use, it must be stored in a clean, dry environment protected from contamination. Follow standard sterile medical device storage guidelines, such as keeping it in its original packaging until use and avoiding exposure to moisture, extreme temperatures, or direct sunlight. Proper storage ensures the device remains safe and effective for its intended procedure.
What regulatory pathway does the Veincare Vein Treatment System follow, and what does this mean for its use?
The Veincare Vein Treatment System has received FDA 510(k) clearance (K241930), meaning it has been deemed substantially equivalent to a predicate device under traditional review standards. This clearance confirms the device meets FDA safety and effectiveness requirements for its intended use in treating venous conditions. Clinicians should ensure they are using the device as described in the labeling and within their scope of practice.
Who is the manufacturer of the Veincare Vein Treatment System, and how can I contact them for support or inquiries?
The manufacturer of the Veincare Vein Treatment System is WONTECH CO., LTD, based in Yuseong-Gu, Daejeon, South Korea. For support or inquiries, you can reach their contact person, Hyunsik Yoon, through the address listed: 64, Techno 8-Ro, Yuseong-Gu, Daejeon, 34028, South Korea. Always verify contact details through official manufacturer channels for accuracy.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241930 | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K251288 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Wontech Co., Ltd
- FDA Applicant
- Wontech Co., Ltd.
Sources (3)
- FDA 510(k) K251288 24 fields · synced Sep 18, 2026
- FDA 510(k) K241930 24 fields · synced May 18, 2026
- FDA UDI e7f096d6-3fb5-48ff-a7eb-7c3d137545c2 34 fields · synced May 26, 2026