Manufacturer
Wuhan Pioon Technology Co., Ltd.Medical Diode Laser, Model S1Pro
Wuhan Pioon Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K231548
- Device name
- Medical Diode Laser, Model S1Pro
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2023-05-30
- Decision date
- 2023-08-03
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
The Medical Diode Laser, Model S1Pro is indicated for use in the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Intended Use
The Medical Diode Laser, Model S1Pro is indicated for use in the treatment of reflux of the saphenous veins associated with varicose veins and varicosities.
Device Description
The Medical Diode Laser uses a wavelength 1470nm Gallium Aluminum Arsenide (GaAlAs) diode laser as the beam source. The laser utilizes a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The Medical Diode Laser (model: S1Pro) is a compact diode laser with a LCD touchscreen for user control. The device is composed of main unit, foot switch, power cord and protective goggles. The fiber delivery system is not included in this device. The device accepts a fiber with single core of 400μm and 600μm in diameter and with SMA905 connectors.
Summary parsed at:2026-06-01 05:33:01 UTC
Predicate devices
2—
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Not ingested
Medical Diode Laser Systems
K231548 references 2 predicate/reference devices
Cited as predicate
1Medical Diode Laser (S1Pro)
1 submission cite K231548 as a predicate