Hairmax® Blog

Taking Charge of Treatment for Your Hair Loss

Whenever a product is introduced to the medical audience it can take a lot of time for doctors to adopt the product for use in their practice. The HairMax LaserComb is no exception to this, and since the clearance for marketing of the device for hair growth in males with pattern baldness in 2007, adoption of the HairMax by the medical audience has not been as fast as we anticipated....

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FDA 510(k) Medical Device Clearance: Efficacy or Just Safety?

The 510(k) submission is the primary mechanism by which medical devices are accepted to the market in the US. The FDA requires data to back equivalence claims, descriptive data and performance data to support this type of submission. There is a general misperception that the FDA clears medical devices for marketing only based on proof of the safety. That assumption is not correct in all cases, as there is also...

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