Medical Diode Laser (Model: L2)

Wuhan Pioon Technology Co., Ltd.

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

Product code GEX· 21 CFR 878.4810

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Product code

GEX
21 CFR 878.4810

Predicate devices

1

Cited as predicate

3

Device details

FDA 510(k) registration fields

K number
K240179
Device name
Medical Diode Laser (Model: L2)
Country / region
China(CN)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2024-01-23
Decision date
2024-03-21
Submission type
Traditional
Technology type
Diode(AI inferred)
Clinical applications
Surgical cuttingVascular treatment
Primary application
Surgical cutting
Classification source
AI classified

Indications for Use

The Medical Diode Laser (Model: L2) is indicated for:
-Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue
-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux

Intended Use

The Medical Diode Laser (Model: L2) is indicated for: -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue -Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux

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: L2) 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 05:27:25 UTC

Predicate devices

1

K240179 references 1 predicate/reference device

Cited as predicate

3

3 submissions cite K240179 as a predicate