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For use in general surgery for the incision, excision, ablation, vaporization, coagulation of soft tissue.
For use in dermatology for incision, excision, ablation and hemostatis of soft tissue.

The New Star Model 130 laser is a compact, portable, self-contained surgical laser system that produces a variable 1-6 watt beam of infrared radiation at 1320nm wavelength. The system emits a pulsed laser beam which is delivered to the treatment site using a fiber optic delivery system. A visible light 0.5 mW HeNe laser beam at 632.8nm is used for aiming.
The system is comprised of a laser console, a fiber-optic delivery system, a foot switch and a removable electronic key interlock. The system provides safety features that are designed to protect the operator and patient from high voltage and laser emissions.

This 510(k) summary for the New Star Model 130 6-Watt Nd:YAG Laser System does not contain any information about acceptance criteria or a study proving the device meets those criteria.

Instead, the summary focuses on demonstrating substantial equivalence to previously cleared devices. It states:

• Nonclinical Performance Data: "none"
• Clinical Performance Data: "none"
• Conclusion: "The New Star Model 130 6-Watt Nd:YAG Laser System is substantially equivalent to other existing surgical laser systems in commercial distribution for the incision, excision, ablation, vaporization and coagulation of soft tissue."

Therefore, I cannot provide the requested information as it is not present in the provided text. This device was cleared based on its similarity to other legally marketed devices, rather than through a performance study against predefined acceptance criteria for a novel technology.

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