# K241791: Medical Diode Laser Systems (GBOX-6H,  GBOX-10D , GBOX-12D,  GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)

- Pathway: 510(k) (Traditional)
- Applicant: Gigaalaser Company, Ltd.
- Decided: Mar 19, 2025 after 271 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: 23 generations back to K943450 (1995). 639 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 641 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222701: MANTA Laser, Squalus Med, Ltd. (2022) Summary page 7.
- K193656: SkyPulse, Fotona D.O.O. (2020) Summary page 7.
- K160952: Alma Diode Tabletop Laser, Alma, Ltd. (2016) Summary page 7.
- K240747: Medical Diode Laser (M2-GK), Wuhan Pioon Technology Co., Ltd. (2024) Summary page 8.

## Most influential descendants
- K262426: Medical Diode Laser (S1Pro+, S1Pro K15, S1Pro N6, S1Pro N75) (2026), 0 descendants of its own

## Indications for use
(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS Il-6H 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 output wavelength of model GBOX-6H and VELAS II -6H is 1940nm. (2) The Medical Diode Laser Systems, model: GBOX-1OD, GBOX-12D is indicated for use in surgical applications requiring the vaporization, incision, excision, ablation, cutting and hemostasis, or coagulation of soft tissue in conjunction with endloscopic 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 output wavelength of model GBOX-10D and GBOX-12D is 1470nm. (3) The Medical Diode Laser Systems, model: GBOX-15D, VELAS II -15D is indicated for use in endovenous occlusion of the greater saphenous vein in patients with superficial vein reflux. The GBOX-15D, VELAS II-15D is further indicated for laser assisted lipolysis. The output wavelength of model GBOX-15D and VELAS II -15D is 1470nm. (4) The Medical Diode Laser Systems, model: VELAS Pro-30B15D 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. Medical Diode Laser Systems, model: VELAS Pro-30B15D is further indicated for laser assisted lipolysis. The output wavelength of model VELAS Pro-30B15D is 980nm or 1470nm.

Source page: https://510kreport.com/device/K241791
Methodology: https://510kreport.com/methodology