Medical Diode Laser Systems (TR-B)
Baoding Te'Anzhou Electronic 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
- K252658
- Device name
- Medical Diode Laser Systems (TR-B)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-08-22
- Decision date
- 2025-11-28
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Surgical cutting
- Primary application
- Surgical cutting
- Classification source
- AI classified
Indications for Use
The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue - Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.
Intended Use
The Medical Diode Laser Systems are intended for delivery of laser light to soft tissue in the contact and non contact mode during surgical procedures. The device's 980nm laser is generally indicated for use in incision, excision, vaporization, ablation, hemostasis or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology. The device is further indicated for laser assisted lipolysis. The device's 1470nm laser is intended for: Incision, excision, ablation, vaporization, hemostasis and/or coagulation of soft tissue-Endovascular coagulation and endovenous occlusion of the greatest saphenous vein in patients with superficial vein reflux.
Device Description
The Medical Diode Laser Systems generate a 980nm wavelength laser to act on a target tissue to achieve resection, hemostasis, ablation, and coagulation of the target tissue. The Medical Diode Laser Systems generate a 1470 nm wavelength laser that acts on the water molecules of the target tissue to achieve the function of treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The Medical Laser Family has following characteristics: Dual wavelengths, Temperature monitoring system. Laser type: GaAlAs diode laser. Device model: TR-B. Wavelength: 980nm±20nm, 1470nm±20nm. Laser output power: 980±20nm cw 20W, 1470nm±20nm cw 15W. Security level: Class I type B. Laser output mode: Continuous, Pulse, Single. Pulse width: 0.1s-10s (stepping 0.1s). Cooling: Air Cooling. Size: 310(L)*290(W)*205(H) mm. Net weight: 7.45KG. Fuse: F15AL250V. Aiming beam: Diode laser of 650nm, power Max. 10mW, adjustable brightness. Beam divergence: 314 mrad to 443 mrad. Application systems: Fiber core diameter: 400μm 600μm, NA≥0.22, With SMA905 connector. Before use must be sterilized. Transmission system: Contact: fibers of 400μm or 600μm with SMA905 connector; Non-contact: fibers and tips. Operation interface: Color LCD touch screen. Power supply: 100-220VAC, 50/60Hz, 2.6-1.0A. Waterproof level: IPX1. Footswitch Waterproof level: IPX8. Transportation & Storage environmental conditions: Temperature:-20°C~70°C, Relative humidity: 10%~90%, Atmospheric pressure: 80KPa~106KPa Without sensible vibration and shock. Application environmental conditions: Temperature:10°C~40°C, Relative humidity: 10%~90%, Atmospheric pressure: 80KPa~106KPa.
Summary parsed at:2026-06-01 05:24:11 UTC
Predicate devices
3—
—
Not ingested
Diode laser therapy device
Medical Diode Laser (Model: L2)
K252658 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K252658 as a predicate
