FDA Clearance: Capillus 272®
The Capillus272 has been cleared by the Food and Drug Admininstration by a 510(k) for the promotion of hair regrowth in adult men and women with androgenic alopecia (AGA) having Ludwig Savin classifications I-II or Norwood Hamilton classifications of IIa-V and Fitzpatrick Classification of Skin phototypes I-IV.
What is an FDA 510(k) Clearance and why is it important?
A 510(k) is a premarket notification made to FDA to demonstrate that a device is safe and effective. For a medical device to be legally marketed in the United States, it must receive clearance by the Food & Drug Administration. Clearance is based on an application by the manufacturer of the device to the FDA. This application may include clinical studies that prove efficacy, as well as safety information, and other evidence showing that the device is has been deemed safe and effective for its intended use.
The double-blind clinical study for the Capillus272 was registered on ClinicalTrials.gov and was managed by a neutral third party.* The clinical trial data indicated that low-level laser treatment of the scalp every other day for 17 weeks with the Capillus272 device, significantly improved hair counts by 51% in those study participants who used the active (non-placebo) device. Subjects were able to use the device on a self-treatment home-use basis and no adverse events or side-effects were reported. The Capillus272 was proven to be a safe and effective treatment for androgenic alopecia as per clearance status above.
*See details of clinical trials at ClinicalTrials.gov