Manufacturer
Wontech Co., Ltd.Veincare
Country / Region:Korea, Republic of (KR)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251288
- Device name
- Veincare
- Company
- Wontech Co., Ltd.
- Country / Region
- Korea, Republic of(KR)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-25
- Decision date
- 2025-05-14
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
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.
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.
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.
Summary parsed at:2026-06-01 05:23:03 UTC
Predicate devices
3Air Gap Fiber
WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
Veincare
K251288 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251288 as a predicate
