# K240644: Medical Diode Laser (S1Pro)

- Pathway: 510(k) (Traditional)
- Applicant: Wuhan Pioon Technology Co., Ltd.
- Decided: Jun 10, 2024 after 95 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.
2 later devices descend from it; 2 cite it directly.
0 of 362 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
- K251049: SurgiLight 1470 Diode Laser System (Model:Halo) (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: 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, 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: S1Pro) is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K240644
Methodology: https://510kreport.com/methodology