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- 980nm 1470nm Diode Laser for Aesthetic Surgery
- 980nm 1470nm Diode Laser for Phlebology And Vascular Surgery
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- 980nm 1470nm Diode Laser for Gynecology
- 980nm 1470nm Diode Laser for Ent
- 980nm 1470nm Diode Laser for Orthopedics
- 980nm 1470nm Diode Laser for Physiotherapy
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- 980nm 1470nm Diode Laser for Podiatry
Semiconductor laser therapy devices<br>TR-B<br>DIODE LASER 980nm+-20nm<br>DIODE LASER 1470nm+-20nm
TR-B
Regulatory Information / Compliance & Safety
Last Updated:7 July 2026
Applicable to:Semiconductor Laser Therapy Device – Model:TR-B
Governing Regulation:EU MDR 2017/745
1. Device Identification
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Attribute |
Details |
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Product name |
Semiconductor laser therapy device |
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Model |
TR-B |
|
UDI-DI |
[06978556800013] |
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Basic UDI-DI |
[697855680TAZ01W2] |
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Classification |
Class IIb(Active Therapeutic Device) |
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Operation mode |
CW, single pulse, pulse |
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Wavelengths |
980nm ± 20nm (20W max); 1470nm ± 20nm (15W max); Aiming beam 650nm ≤ 10mW |
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Intended Purpose |
The Semiconductor laser therapy devices(Model: TR-B) contains 2 wavelengths: 980nm and 1470nm. The 980nm wavelength is indicated for use in treatment and surgery, which delivers laser energy to target tissues that need to be vaporized, incised, excised, ablated, cut and hemostatic or coagulated, and is suitable for specialties such as anorectal surgery and gynecology. The 1470nm wavelength is intended for the treatment of saphenous vein reflux associated with varicose veins and varicosities. |
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Product Images |
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2. Manufacturer & Authorized Representatives
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Entity |
Details |
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Manufacturer Information |
Name: Baoding Te'anzhou Electronic Technology Co., Ltd. Address: Room 1702, 17th Floor, Zhibo Technology Comprehensive Research And Development Building,89 Hengbin Road, Baoding, Hebei, China Tel: +86-18331271987 Web: www.tazmedicalaser.com |
|
EU Authorized Representative |
Name: MedPath Gmbh Address:Mies-van-der-Rohe-Strasse 8 80807 Munich,Germany Contact:Zejian Yang Tel:+49(0)89 81306837 |
|
UK Authorized Representative |
Name: Abmed Medical Technology Group Ltd Address:52A Westerham Road, Sevenoaks, England, TN132PZ, United Kingdom Contact:Gloria Wang Tel: +44 7388 038 766 |
3. Safety and Performance Information (GSPR 23.1)
3.1 Contraindications
It is contraindicated for patients with heart disease, mental illness, hypertension or who have been proven to be unsuitable for laser treatment.
Applications at the central nervous system and the central circulatory system are not allowed.
The use of the optical fiber probe in the vicinity of brackets or implants is not allowed because there is the risk of heating and destruction
The use of the subject device is contraindicated if, in the opinion of the attending physician, the surgical method as such is contraindicated or if the patient is not able to undergo surgery or anesthesia due to his or her general condition.
3.2 Warnings & Precautions
Eye Protection:The device is a Class 4 Laser Product. Direct or scattered radiation can cause irreversible retinal damage. All personnel must wear protective eyewear (OD ≥ 4 for 800–1700nm) during operation. Nominal Ocular Hazard Distance (NOHD) is 10.5 m.
Fire Hazard:Do not use near flammable anesthetics, alcohol-based antiseptics, or other combustible materials (drapes, paper).
Electrical Safety: Ensure proper grounding. Do not remove the cover; maintenance must be performed by TAZLASER-authorized personnel.
EMC:Do not use adjacent to diathermy, electrocautery, or strong RF emitters. Maintain recommended separation distances from mobile RF communications equipment (see IFU Section 4.10).
Fiber Handling:Do not excessively bend the fiber (minimum bend radius must be maintained). Ensure fiber is securely connected before emission.
3.3 Residual Risks
Despite the implementation of comprehensive safety measures, inherent risks associated with the use of a Class 4 laser and surgical procedures cannot be entirely eliminated. These residual risks have been evaluated in the Clinical Evaluation Report (CER, Document No. TAZ-CE-TD11) and are summarized below:
General Residual Risks (Applicable to all indications):
Ocular Injury:Direct or scattered laser radiation can cause irreversible retinal burns or blindness. (Mitigated by mandatory use of safety goggles).
Skin Burns:Misapplication or excessive power density may cause thermal injury to non-target tissue.
Fire Hazard:Laser energy may ignite flammable materials (e.g., drapes, alcohol-based antiseptics).
Indication-Specific Residual Risks:
Varicose Veins (1470nm):Deep Vein Thrombosis (DVT), Pulmonary Embolism, skin burn, hematoma, ecchymosis, edema, paresthesia.
Anorectal Surgery (980nm):pain, mild bleeding, transient urinary retention,major bleeding, infection, organ injury .
Gynecology (980nm):postoperative bleeding, massive hemorrhage, perforation .
3.4 Performance Characteristics
Standards Compliance: EN IEC 60601-1, EN IEC 60601-1-2, EN IEC 60601-2-22, IEC 60825-1, IEC 62366-1.
Output Stability: Deviation between actual and set laser output ≤ ±10% (Essential Performance).
Laser Class:Class 4 (High Power).
Applied Part:Type B.
Ingress Protection:IPX1 (Main Unit); IPX8 (Foot Switch).
Service Life:5 years (operational period).
Effectiveness:The device achieves targeted tissue ablation and hemostasis with reduced intraoperative bleeding compared to conventional electrosurgery.
4. Post-Market Surveillance & Safety Updates
Field Safety Notices (FSNs):
There are currently no active Field Safety Notices for this device.
In the event of a safety corrective action (FSCA), this section will be updated immediately in accordance with MDR Article 87.
Reporting Incidents:
Users are legally obliged to report any serious incidents involving this device to both the manufacturer and the relevant Competent Authority.
Manufacturer Vigilance Contact:lvan@tazlaser.com
EU AR Contact: MedPath GmbH (details above)
5. Compatible Accessories
To ensure safety and performance, only compatible accessories meeting the following specifications shall be used:
|
Accessory |
Specification |
Requirement |
|
Optical Fiber |
Core Diameter: 400μm (980nm) or 600μm (1470nm) |
Mandatory |
|
Safety Goggles |
Optical Density (OD) ≥ 4 for 800–1700nm |
Mandatory |
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Foot Switch |
IPX8 rated, compatible connector |
Provided |
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The use of optical fiber not specified as compatible may result in equipment damage, inadequate therapeutic efficacy, and is strictly prohibited. |
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6. Contact for Regulatory Inquiries
For regulatory support, technical files, or additional compliance information, please contact:
Quality Department
Baoding Te'anzhou Electronic Technology Co., Ltd.
Email: lvan@tazlaser.com
Tel: +86-18331271987
Baoding Te'anzhou Electronic Technology Co., Ltd. (TAZLASER© 2026). All rights reserved. The appearance, hardware control system, and control software are protected by copyright. This document or its contents may not be disclosed to third parties or copied without express written permission. Last updated: 7 July 2026.