Manufacturer
Micro-Energy Medical Technology Co., Ltd.SurgiLight 1470 Diode Laser System (Model:Halo)
Micro-Energy Medical Technology Co., Ltd.
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
- K251049
- Device name
- SurgiLight 1470 Diode Laser System (Model:Halo)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-04-03
- Decision date
- 2025-07-02
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The SurgiLight 1470 Diode Laser System (Model: Halo) 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.
Intended Use
The SurgiLight 1470 Diode Laser System (Model: Halo) 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.
Device Description
The SurgiLight 1470 Diode Laser System (model: Halo) incorporates a 1470nm wavelength Gallium Arsenide (GaAs) diode laser for producing its therapeutic effects. The device also incorporates a red (650nm) aiming beam diode to indicate the area to be irradiated by the laser beam. The device is composed of the main unit, footswitch, a power cord and remote interlock components. The device incorporates an LCD touchscreen for the device user to set output parameters and for control of the device. The device transmits the laser output via optical fibers with SMA905 connectors.
Summary parsed at:2026-06-01 05:22:46 UTC
Predicate devices
2neoV980 & neoV1470 Diode Lasers
Medical Diode Laser (S1Pro)
K251049 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251049 as a predicate
