# K250656: Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)

- Pathway: 510(k) (Special)
- Applicant: Wuhan Pioon Technology Co., Ltd.
- Decided: Apr 4, 2025 after 30 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 24 generations back to K943450 (1995). 636 ancestors in all.
No later device cites it as a predicate yet.
0 of 637 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240747: Medical Diode Laser (M2-GK), Wuhan Pioon Technology Co., Ltd. (2024) Summary page 5.
- K240179: Medical Diode Laser (Model: L2), Wuhan Pioon Technology Co., Ltd. (2024) Summary page 5.
- K230274: Medical Diode Laser (M2), Wuhan Pioon Technology Co., Ltd. (2023) Summary page 5.

## 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 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.

Source page: https://510kreport.com/device/K250656
Methodology: https://510kreport.com/methodology