What does "FDA Cleared" mean?

The term “FDA Cleared” means that the US Food & Drug Administration has specifically authorized a medical device by a particular manufacturer to be marketed as both safe and effective treatment for the intended use based on evidence provided to the FDA by the manufacturer.

In the case of Capillus laser therapy caps, all of our hair regrowth devices have been cleared by the US FDA as safe and effective for treatment of hereditary hair loss for both men and women as follows: Capillus caps are intended to treat Androgenetic Alopecia and promote hair growth in: males who have Norwood Hamilton Classifications of II-a to V patterns of hair loss; and females who have Ludwig (Savin) scale Classifications Class I-1 to Class I-IV, Class II-1, or frontal patterns of hair loss; both with Fitzpatrick Skin Types 1 to 4.

Capillus Laser technology has been deemed safe and effective by the FDA, our extended network of physician partnerships, and through clinical trials.

*For more information please go to Capillus.com/fda-clearance