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The Ceralas D 980 is intended for delivery of laser light to soft tissue in the contact or non-contact mode during surgical procedures, including via endoscopes, introducers, or catheters. The Ceralas D 980 is generally indicated for incision. excision, vaporization, ablation, hemostasis, or coagulation of soft tissue in ear, nose and throat and oral surgery (otolaryngology), dental procedures, arthroscopy, gastroenterology, general surgery, dermatology, plastic surgery, podiatry, urology, gynecology, neurosurgery (peripheral nervous system), pulmonary surgery, and cardiothoracic surgery. This Ceralas D 980 is specifically indicated for hemostasis and coagulation of soft tissue (including cardiac tissue) and laser assisted lipolysis.

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The provided 510(k) summary for the Biolitec Inc.'s Ceralas Diode 980nm Laser System (Models D15, D25) states "No performance data is being submitted" (page 5). Therefore, there is no information available within this document to describe acceptance criteria or a study proving the device meets acceptance criteria.

The device's substantial equivalence to predicate devices is based on having the "same intended uses and similar indications, technological characteristics, and principles of operation". The document asserts that "The minor technological differences between the Ceralas D and its predicate devices raise no new issues of safety or effectiveness."

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