Veincare Vein Treatment System (GEX) by WONTECH

Regulatory status

as of registry sync 22 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Special	NumberK251288	Date14 May 2025Cleared	StatusActive
United States	GUDID listing GUDID	Number08800022301404 UDI-DI	Date17 Dec 2024Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE 510(k) Substantially Equivalent · Traditional	NumberK241930	Date14 Nov 2024Cleared	StatusActive

Official records

AccessGUDID record UDI-DI 08800022301404
FDA 510(k) database 510(k) number K251288
FDA 510(k) database 510(k) number K241930

Across registries

2 registries list this device

FDA 510(k) K251288 decided 14 May 2025 Active· +1 more in the status table
FDA GUDID UDI-DI 08800022301404 listed 17 Dec 2024 Listed

Timeline

3 dated events

14 Nov 2024 Cleared FDA 510(k) K241930
17 Dec 2024 Listed FDA GUDID 08800022301404
14 May 2025 Cleared FDA 510(k) K251288

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

510(k) · GUDID

Generic name: General/multiple surgical diode laser system
Model / reference: Veincare
FDA applicant: Wontech Co., Ltd.

Primary DI / UDI-DI: 08800022301404
510(k) Number: K251288
K241930
FDA product code: GEX
GMDN term: General/multiple surgical diode laser system

Device class: Class II
Regulation: 21 CFR Part 878.4810
Advisory committee: General, Plastic Surgery
FDA decision: SESE Substantially Equivalent
GUDID distribution status: In Commercial Distribution

cited in the FDA summary

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cites

Venacure 1470 Pro K181632 17 Sep 2018 FDA record · FDA summary
Medical Diode Laser Systems K160549 7 Apr 2017 FDA record · FDA summary

Source: 510k-lineage (choiben314), CC BY 4.0

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

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.

Devices cleared under K241930

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

This record carries 2 submission numbers: K241930, K251288. The table lists K241930.

Devices cleared under K241930
		UDI-DI	Size and differences
Veincare WONTECH CO., LTD	Veincare	08800022301404	—	On the market

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Other devices filed under FDA product code GEX (Powered Laser Surgical Instrument).

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Properties

Prescription use
Serial number
Manufacturing date

Other properties (12, all answered No)