What is the FDA warning about Capillus products?

The FDA has issued a warning about Capillus products, which are laser therapy devices marketed for hair regrowth in individuals with pattern hair loss. The warning pertains to the promotion and sale of products that have not been adequately proven to be safe or effective for those purposes. Without thorough evidence from rigorous clinical studies confirming safety and efficacy, the FDA expresses concern that consumers may be misled. Legitimate Capillus devices have indeed received FDA clearance, suggesting they are not expected to cause harm and provide a moderate benefit; however, this does not equate to formal approval based on extensive testing, typical of drugs. Thus, the warning underscores the need for consumers to critically evaluate marketing claims and seek appropriate medical consultation when considering such medical devices for treatment.