Manufacturer
Gigaalaser Company , Ltd.Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K241791
- Device name
- Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
- Company
- Gigaalaser Company , Ltd.
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2024-06-21
- Decision date
- 2025-03-19
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
(1) The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-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 specialists 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-10D, 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 endoscopic equipment for medical specialists 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 specialists 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.
Intended Use
The Medical Diode Laser Systems, model: GBOX-6H, VELAS II-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. The Medical Diode Laser Systems, model: GBOX-10D, 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 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-10D and GBOX-12D is 1470nm. 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. 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.
Device Description
The Medical Diode Laser Systems include model: GBOX-6H, VELAS II-6H, GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D, VELAS Pro-30B15D which consist of three main components: Main device; Foot switch; Accessories. Diode laser is a kind of laser with semiconductor as working material. It consists of working material, cavity resonator and power source. The diode laser for this unit is GaAlAs diode bar, and the wavelength is 1940nm for GBOX-6H, VELAS II-6H; 1470nm for GBOX-10D, GBOX-12D, GBOX-15D, VELAS II-15D; 980nm or 1470nm for VELAS Pro-30B15D. It features impact structure, high efficiency and long lifetime. Generally, the beam shall be emitted as the big beam divergence of the laser from the diode. With the unique fiber-coupling technology, the laser beam can be coupled efficiently into the fiber. MCU (Micro Controller Unit) is the control center of system. MCU controls the drive board and temperature system by changing operating current. The operating power supply is the power source of the whole system. It supplies power for MCU, diode laser module by DC-DC conversion module and temp system by temp-control circuit. MCU controls the drive current of diode laser module by adjusting the DC-DC module and current-control circuit. The MCU has three external input sources: footswitch, remote interlock connector and information input from the touch units, it has one external output unit: display terminal. The diode laser module provides laser power output by fiber with optical fiber coupling system.
Summary parsed at:2026-06-01 05:21:11 UTC
Predicate devices
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K241791 references 5 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K241791 as a predicate
