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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

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Company

Baoding Te'Anzhou Electronic Technology Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K252564
Device name
Medical Diode Laser Systems (VeinCure)
Company
Baoding Te'Anzhou Electronic Technology Co., Ltd.
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

2

K252564 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

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