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It is intended for use in dermatology for photothermolysis, for the specific indications {in adults (18 years or older)} to remove blue-black tattoos, or to remove or lighten benign epidermal pigmented lesions.

The Sharplan Ruby Laser System is a surgical laser which is capable of providing pulsed laser energy of a 694.3 nm wavelength through an articulated arm beam delivery system. While observing and directing the aiming beam (633 nm, HeNe), the treatment beam is administered by the physician through a foot switch.

The provided text does not contain information about acceptance criteria or a study that proves a device meets such criteria. Instead, it is a 510(k) Summary for a Sharplan Lasers, Inc. Ruby Laser System, focusing on its substantial equivalence to predicate devices and its intended use.

Specifically, the text states: "No new indications were sought in this premarket notification and no clinical data was presented." This indicates that no clinical studies were conducted for this submission, and therefore, no performance criteria or study results are available.

Therefore, I cannot provide the requested information.

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