Press Release – New Laser Cleared by FDA for Female Hair Loss

Snippet from the press release:

The United States Food and Drug Administration (FDA) has just cleared a new laser proven to regrow hair in women. The FDA ruling was based on a study performed by Dr. Grant Koher which showed that low level laser light, specifically with a precise wavelength, provides a medically significant treatment for women’s hair loss. Dr. Koher is the first physician to conduct a study resulting in 510k FDA clearance for a medical device for the treatment of female pattern baldness.

Dr. Koher conducted a three phased medical study to confirm that females with androgenetic alopecia, when exposed to scheduled applications of low level laser light, would have a reduction in hair loss and promotion in hair growth. This study was conducted over 18 months with 82 qualified participants. Each participant was scheduled to receive 52 treatments of 20 minute duration, over a period of 26 weeks. All study procedures included clinical protocol, clinical tracking, and clinical analysis approved by the Western Institutional Review Board (WIRB).

Read the full PR — New Laser Cleared by Food and Drug Administration for the Treatment of Female Pattern Hair Loss

The study that is referenced was done by Dr. Koher in North Carolina, but I can’t find any information about it outside of this press release (not even on the doctor’s website). He apparently presented the study, “Effect of Laser Biostimulation In The Treatment of Female Pattern Hair Loss“, at last year’s ISHRS (International Society of Hair Restoration Surgery) meeting, but I can’t find any evidence that it was published anywhere.

Note that it is not FDA approved, but it is “cleared”. When the FDA clears something like this technology, it means that it is safe… not necessarily effective. For more information on 510(k) clearance, see here.