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Meladine™ Natural Melanin Enhancer is indicated as a topical pretreatment prior to undergoing laser hair removal for patients suffering from unwanted, non-pigmented hair growth (white, grey, light blonde) who are unlikely to experience hair reduction with laser treatment alone.

Meladine™ Natural Melanin Enhancer (Accessory to Surgical Laser Instruments used for Hair Removal)

This document is a 510(k) premarket notification letter from the FDA regarding the Meladine™ Natural Melanin Enhancer. It indicates substantial equivalence to a predicate device and provides regulatory information for marketing. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance, ground truth types, or training set details.

Therefore, I cannot provide the requested information based on the provided text. The document is primarily a regulatory approval letter, not a technical report detailing a study.

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