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

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Product code

GEX
21 CFR 878.4810

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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

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