Medical Diode Laser Systems (VeinCure)
Baoding Te'Anzhou Electronic Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
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
- K252564
- Device name
- Medical Diode Laser Systems (VeinCure)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-14
- Decision date
- 2025-11-07
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The "VeinCure" is indicated for use in the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Intended Use
The "VeinCure" is indicated for use in the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Device Description
Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs (Gallium-aluminum-arsenic) diode bar, and the wavelength is 1470nm. It features impact structure, high efficiency and long lifetime.
Summary parsed at:2026-06-01 05:24:05 UTC
Predicate devices
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Not ingested
Medical Diode Laser Systems
K252564 references 2 predicate/reference devices
Cited as predicate
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