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510(k) Data Aggregation
K Number
K250656Device Name
Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
Manufacturer
Wuhan Pioon Technology Co.,Ltd.
Date Cleared
2025-04-04
(30 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Pioon Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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K Number
K240747Device Name
Medical Diode Laser (M2-GK)
Manufacturer
Wuhan Pioon Technology Co.,Ltd.
Date Cleared
2024-06-17
(90 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Pioon Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Diode Laser (Model: M2-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 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: M2-GK) is further indicated for laser assisted lipolysis.
Device Description
The Medical Diode Laser device incorporates a dual wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects, it is designed to deliver continuous or pulsed, infrared laser energy at wavelengths of 980mm and 1470nm respectively. The device also incorporates a red (650mm) 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 200um, 400μm, 600μm, 800μm and 1000um diameter respectively.
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K Number
K240644Device Name
Medical Diode Laser (S1Pro)
Manufacturer
Wuhan Pioon Technology Co.,Ltd.
Date Cleared
2024-06-10
(95 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Pioon Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Medical Diode Laser (Model: S1Pro) 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, Headineck/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: S1Pro) is further indicated for laser assisted lipolysis.
Device Description
The Medical Diode Laser device incorporates a 1470nm wavelength Gallium Aluminum Arsenide (GaAlAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) 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 transmits the laser output via third-party optical fibers with SMA905 connectors and with single cores of 400um and 600um diameter respectively.
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K Number
K230274Device Name
Medical Diode Laser (M2)
Manufacturer
Wuhan Pioon Technology Co.,Ltd.
Date Cleared
2023-03-31
(58 days)
Product Code
GEX
Regulation Number
878.4810Why did this record match?
Applicant Name (Manufacturer) :
Wuhan Pioon Technology Co.,Ltd.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Medical Diode Laser is intended to incision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.
Device Description
The Medical Diode Laser use a wavelength 1940nm Galium 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: M2) 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 include in this device. The device accepts a fiber with single core of 400um and 600um in diameter and with SMA905 connectors.
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