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510(k) Data Aggregation
(98 days)
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.
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
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