# K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Pioon Technology Co., Ltd.
- Decided: Sep 10, 2026 after 56 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). 644 ancestors in all.
No later device cites it as a predicate yet.
0 of 645 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K252658: Medical Diode Laser Systems (TR-B), Baoding Te'Anzhou Electronic Technology Co., Ltd. (2025) Summary page 6.
- K240179: Medical Diode Laser (Model: L2), Wuhan Pioon Technology Co., Ltd. (2024) Summary page 6.
- K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D), Gigaalaser Company, Ltd. (2025) Summary page 6.
- K230274: Medical Diode Laser (M2), Wuhan Pioon Technology Co., Ltd. (2023) Summary page 6.

## Indications for use
The Medical Diode Laser (Model: S1Pro+) is intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device’s 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device’s 1470nm laser is intended 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. The Medical Diode Laser (Model: S1Pro K15) 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. -Laser assisted lipolysis. The Medical Diode Laser (Model: S1Pro N6) 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. The Medical Diode Laser (Model: S1Pro N75) is intended to incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue.

Source page: https://510kreport.com/device/K262426
Methodology: https://510kreport.com/methodology