Medical Diode Laser Systems (TR-B)

The Medical Diode Laser Systems (TR-B) is a dual-wavelength surgical laser device designed to deliver 980nm and 1470nm laser light to soft tissue in contact and non-contact modes. The 980nm wavelength is indicated for incision, excision, vaporization, ablation, hemostasis, and coagulation across multiple surgical specialties including otolaryngology, general surgery, dermatology, and plastic surgery, as well as laser-assisted lipolysis. The 1470nm wavelength is intended for endovascular coagulation and endovenous occlusion of the saphenous vein in patients with superficial vein reflux.

The device generates 980nm±20nm at 20W continuous power and 1470nm±20nm at 15W continuous power, with adjustable pulse durations from 0.1 to 10 seconds. It features air cooling, a color LCD touch screen interface, a 650nm red aiming beam (max 10mW), fiber delivery systems with 400μm or 600μm core diameter via SMA905 connector, and operates on 100-220VAC power supply. Key differences from the predicate include a slightly wider wavelength tolerance (±20nm vs ±5-10nm) and a broader pulse duration range (0.1-10 seconds).

IEC 60601-1:2020-08 (general safety), IEC 60601-1-2:2020-09 (electromagnetic compatibility), IEC 60601-2-22:2019-11 (surgical laser equipment), IEC 60825-2007-03 (laser equipment classification), IEC 60601-1-6:2020-07 (risk management), and IEC 60601-4-2:2016-05 (electromagnetic immunity). Software verification and validation testing per FDA guidance on device software, plus usability testing and performance testing to validate output specifications.