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The Surgical Lightstic" 180 is intended to be used as a surgical instrument for coagulation of soft tissue in conjunction with or without endoscopic equipment (including laparoscopes, hysteroscopes, bronchoscopes, cystoscopes, gastroscopes, colonoscopes), and coagulation of soft tissue in the contact mode in both open or closed surgical procedures (with or without handpiece).

The Surgical Lightstic™ 180 is indicated for use in medicine and surgery with 980 - 1064 nm wavelength laser energy in the following surgical specialties: General Surgery, Plastic Surgery, and Dermatology.

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This document is a 510(k) summary for the Surgical Lightstic™ 180, a laser fiber device. It demonstrates substantial equivalence to predicate devices. The document explicitly states: "Performance Data: None required."

Therefore, based on the provided text, there is no acceptance criteria or study described proving the device meets acceptance criteria. The submission relies on demonstrating substantial equivalence to predicate devices, which means it asserts that its technological characteristics and intended use are similar enough to already legally marketed devices that it does not raise new questions of safety or effectiveness.

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