Manufacturer
Wuhan Pioon Technology Co., Ltd.Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
Wuhan Pioon Technology Co., Ltd.
Country / Region:China (CN)Submission type:Special
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K250656
- Device name
- Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-03-05
- Decision date
- 2025-04-04
- Submission type
- Special
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Medical Diode Laser (Model: MZ-GK) is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialists including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures. The Medical Diode Laser (Model: MZ-K20) is indicated for: - Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue. - Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: MZ-N75) is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue. The Medical Diode Laser (Model: MZ-GK) is further indicated for laser assisted lipolysis. Use of Device Rx only.
Intended Use
The Medical Diode Laser (Model: MZ-GK) is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endoscopic equipment for medical specialist including: Urology, Thoracic Surgery, Plastic Surgery and Dermatology, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery, Gastroenterology, Head/neck/ENT and Radiology, Oral Surgery and Dental procedures, Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: MZ-GK) is further indicated for laser assisted lipolysis. The Medical Diode Laser (Model: MZ-K20) is indicated for: -Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue. -Endovascular coagulation and endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The Medical Diode Laser (Model: MZ-N75) is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
Device Description
The Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) incorporates a solid state diode as laser energy source for producing its therapeutic effects, it is designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980nm and 1470nm respectively for MZ-GK, 1470nm for MZ-K20 and 1940nm for MZ-N75. The device also incorporates a red (650nm) or green(532nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, foot switch, power cord, and protective goggles. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 200μm, 300μm, 400μm, 600μm, 800μm and 1000μm diameter respectively.
Summary parsed at:2026-06-01 05:22:30 UTC
Predicate devices
3Medical Diode Laser (M2)
Medical Diode Laser (Model: L2)
Medical Diode Laser (M2-GK)
K250656 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K250656 as a predicate
