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The Accure Laser System is indicated for the long-term treatment of mild to severe inflammatory acne vulgars.

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The provided FDA 510(k) clearance letter for the "Accure Laser System" does not contain any information regarding acceptance criteria or a study that proves the device meets those criteria.

This document is a letter from the FDA stating that they have reviewed the 510(k) premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. It outlines regulatory requirements and general information about FDA processes but does not detail the specific performance studies or data used to support the substantial equivalence claim.

Therefore, I cannot provide the requested information based solely on the provided text. To answer your questions, additional documentation, such as the actual 510(k) summary or a clinical study report, would be needed.

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