Medical Diode Laser Systems (BERYLAS-12N); Medical Diode Laser Systems (BERYLAS-15N); Medical Diode Laser Systems (HARLAS-45JN); Medical Diode Laser Systems (HARLAS-46JN)

The BERYLAS-15N and the BERYLAS-12N are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The HARLAS-46JN/HARLAS-45JN 1470nm: Indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. 980nm: 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 (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.

The BERYLAS-15N and the BERYLAS-12N are indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. The HARLAS-46JN/HARLAS-45JN 1470nm: Indicated for the treatment of reflux of the saphenous veins associated with varicose veins and varicosities. 980nm: 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 (BPH), Genitourinary (Urology), Thoracic Surgery, Plastic Surgery and Dermatology, Aesthetics including vascular lesions and hair removal, General Surgery, Ophthalmology, Orthopedics, Podiatry, Arthroscopy, Spinal Surgery, Gynecology, Pulmonary Surgery, Neurosurgery (PLDD), Gastroenterology, Head/neck/ENT and Radiology Endovascular coagulation, Oral Surgery and Dental procedures, laser assisted lipolysis.

Medical Diode Laser Systems is Class 4 Laser Product according to 21CFR 1040.10 and IEC 60825-1:2014, which utilizes a solid state diode as a semiconductor source for invisible infrared radiation wavelength. The working beam of BERYLAS-15N and BERYLAS-12N is 1470nm, the working beam of HARLAS-46JN and HARLAS-45JN are 1470nm and 980nm. The max. Laser output power of BERYLAS-15N is 15W, the max. Laser output of BERYLAS-12N is 12W, the max. Laser output power of HARLAS-46JN is 16W for 1470nm and 30W for 980nm and the max. Laser output power of HARLAS-45JN is 15W for 1470nm and 30W for 980nm. The energy is delivered to the treatment site via flexible fiber connected with the Laser Aperture. The treatment parameters, such as, Power, Laser Emission Mode, Interval and Duration (for Pulse modes), and treatment time, can be set via the embedded software. Although Fiber is not a component of BERYLAS-12N, BERYLAS-15N, HARLAS-45JN and HARLAS-46JN, a compatible fiber is required to delivery laser energy to the patient. MED-Fibers Surgical Laser Fibers (core diameter size 600µm) manufactured by MED Fibers, Inc. are recommend, their 510(K) number is K124003.