# K240747: Medical Diode Laser (M2-GK)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Pioon Technology Co., Ltd.
- Decided: Jun 17, 2024 after 90 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: 21 generations back to K943450 (1995). 359 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 364 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152722: neoV980 & neoV1470 Diode Lasers, G.N.S Neolaser, Ltd. (2015) Summary page 5.
- K100558: Quanta Diode Laser System, Quanta System Spa (2010) Summary page 6.

## Most influential descendants
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D) (2025), 1 descendant of its own
- K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) (2026), 0 descendants of its own
- K250656: Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75) (2025), 0 descendants of its own
- K243037: Diode Laser System model Dawn-S (2024), 0 descendants of its own

## Indications for 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, 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: M2-GK) is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K240747
Methodology: https://510kreport.com/methodology