Search Results

The MediDiode is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hair regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Not Found

I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "Medidiode." This letter indicates that the FDA has reviewed the device and determined it to be substantially equivalent to legally marketed predicate devices.

However, this document does not contain the specific information required to answer your request about acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment. The letter primarily outlines regulatory compliance and does not describe the technical performance evaluation or clinical study results in detail.

Therefore, I cannot extract the requested information from the provided text.

Ask a specific question about this device