Manufacturer
Wuhan Pioon Technology Co., Ltd.Medical Diode Laser (Model: L2)
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
- 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
1SkyPulse
K240179 references 1 predicate/reference device
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3Heager Medical Laser Family (Sabrina/Adolf)
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
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3 submissions cite K240179 as a predicate
