FDA Clearance

Capillus FDA ClearedThis page provides the most current information on the status of FDA clearances for specific Capillus® devices. This page may be updated frequently. Visitors are invited to bookmark this page and visit regularly to stay up-to-date with new developments and clearances.

FDA Clearance: Capillus82, Capillus202, Capillus272 Pro & Capillus272 OfficePro

The Capillus82, Capillus202, Capillus272 Pro and the Capillus272 OfficePro have been cleared by the Food and Drug Admininstration by a 510(k) for the promotion of hair regrowth in males and females with androgenic alopecia (AGA) who have Ludwig Savin classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton classifications of IIa-V; and both genders having Fitzpatrick Classification of Skin Phototypes I to IV.

For details on the FDA 510(k) clearances for Capillus laser therapy devices, see below:

  • Click to read about the FDA 510(k) clearance for the Capillus82
  • Click to read about the FDA 510(k) clearance for the Capillus202
  • Click to read about the FDA 510(k) clearance for the Capillus272 Pro
  • Click to read about the FDA 510(k) clearance for the Capillus272 OfficePro
  • Click to read about the Capillus’ FDA 510(k) clearance for men

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.

Consumers and physicians alike should be aware of the dangers and risks associated with purchasing a device without FDA clearance. Click here to read our consumer warning.

Capillus Clinical Trial

The double-blind clinical study for the Capillus272 Pro 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 Pro 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 Pro 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

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