# K243037: Diode Laser System model Dawn-S

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
- Decided: Dec 26, 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: 22 generations back to K943450 (1995). 372 ancestors in all.
No later device cites it as a predicate yet.
0 of 373 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212734: Diode laser therapy device, Triangel Rsd Limited (2023) Summary page 6.
- K240747: Medical Diode Laser (M2-GK), Wuhan Pioon Technology Co., Ltd. (2024) Summary page 6.
- K240644: Medical Diode Laser (S1Pro), Wuhan Pioon Technology Co., Ltd. (2024) Summary page 6.

## Indications for use
The Diode Laser System model Dawn-S is indicated for incision, excision, ablation, vaporization, and coagulation of body soft tissues in surgical application. The 980nm diode laser is generally indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue, including: general surgery, ENT (ear, nose, and throat) and oral surgery (otolaryngoloty), dental procedures, dermatology, plastic surgery, podiatry, urology, gastroenterology, and gynecology. The laser is further indicated for laser assisted lipolysis. The 1470nm diode laser 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 laser is further indicated for laser assisted lipolysis.

Source page: https://510kreport.com/device/K243037
Methodology: https://510kreport.com/methodology