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The Braun Skin i.expert Hair Removal Device is indicated for the removal of unwanted hair. The Braun Skin i.expert is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.

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I am sorry, but the provided text does not contain information about acceptance criteria, device performance, study details, or ground truth establishment for the Braun Skin i.expert device. The document is an FDA 510(k) clearance letter confirming that the device is substantially equivalent to a legally marketed predicate device and outlines general regulatory information and compliance requirements. It also includes the official Indications for Use statement for the device. Details regarding the technical aspects of the device's performance, the studies conducted, and the methodology for establishing ground truth are not present in this document.

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