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Medical Diode Laser, Model S1Pro

Wuhan Pioon Technology Co., Ltd.

Country / region:China (CN)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Wuhan Pioon Technology Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

1
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Device details

FDA 510(k) registration fields

K number
K231548
Device name
Medical Diode Laser, Model S1Pro
Company
Wuhan Pioon Technology Co., Ltd.
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

K231548 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K231548 as a predicate