Search Results

The BRAUN Silk.expert Pro 5 Hair Removal Device is indicated for the removal of unwanted hair. The BRAUN Silk.expert Pro 5 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.

Not Found

Based on the provided text, it is not possible to describe the acceptance criteria and the study that proves the device meets the acceptance criteria.

The document is an FDA 510(k) clearance letter for the CyDen Limited BRAUN Silk.expert Pro 5 Hair Removal Device. This letter confirms that the device is substantially equivalent to a legally marketed predicate device.

However, the letter itself does not contain the detailed information about the performance study, acceptance criteria, or ground truth establishment that you are requesting.

A 510(k) clearance primarily relies on demonstrating substantial equivalence, and while performance data is submitted to the FDA, it is typically not fully detailed within the public clearance letter.

To answer your questions, one would need access to the full 510(k) submission, which is generally not publicly available in this level of detail. The provided text only confirms the device's clearance and its intended use.

Ask a specific question about this device