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The Hair Boom 69 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications I - II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa - V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.

The Hair Boom 69 diode laser is configured within an outer helmet and protective inner liner. The use of diode lasers provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.

I am sorry, but the provided text does not contain information about acceptance criteria or a study proving that the device meets them.

The document is a 510(k) Premarket Notification from the FDA, and it focuses on demonstrating substantial equivalence to a previously cleared predicate device (K192425). It explicitly states:

• "No clinical studies were considered necessary and performed."
• The aim of the submission is "limited to the controller design change."

Therefore, I cannot provide the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies for this submission. The basis for clearance is that the device, with its minor design change to the controller, is substantially equivalent to an already cleared device, and thus, new performance studies were not required by the FDA for this particular submission.

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