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The Venus Silk.expert Hair Removal System is indicated for the removal of unwanted hair. The Venus Silk.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 regimen.

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I am sorry, but the provided text from the FDA 510(k) clearance letter (K170734 for Venus Silk.expert) does NOT contain any information about acceptance criteria, the study that proves the device meets acceptance criteria, sample sizes for test or training sets, data provenance, expert qualifications, ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

The document is a standard FDA clearance letter confirming substantial equivalence to a predicate device for the Venus Silk.expert Hair Removal System. It details:

• The device name and regulation numbers.
• The indications for use (removal of unwanted hair, permanent reduction in hair regrowth).
• That it is cleared for Over-The-Counter Use.
• General FDA compliance information.

To answer your request, you would need different documentation, such as the full 510(k) submission, clinical study reports, or performance testing data, which are not included in this FDA clearance letter.

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