This 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, CapillusPro & Capillus272 OfficePro
The Capillus82, Capillus202, CapillusPro (formerly the Capillus272 Pro) and the Capillus272 OfficePro have been cleared by the Food and Drug Administration by a 510(k) for the promotion of hair regrowth in males and females with androgenic alopecia (AGA) who have Ludwig Savin scale Classifications I-II, and in males with androgenic alopecia who have Norwood Hamilton classifications of I-V; and both genders having Fitzpatrick Skin Types 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 CapillusPro
Click to read about the FDA 510(k) clearance for the Capillus272 OfficePro
Click to read about the FDA 510(k) clearance for the CapillusRX
Click to read about the FDA 510(k) clearance for Capillus devices OTC (Over-The-Counter) use
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.
Why do some medical devices & drugs have FDA approvals, whereas others only have FDA clearance? What is the difference?
The FDA only grants “Approvals” for drugs and medical devices that are either: 1) categorized as a Class III (which means they are life-threatening, life-sustaining, implanted or present unreasonable risk of injury or illness) or; 2) are new products that contain new materials or differ in design from that which is already on the market.
If there is a medical device that has already been approved by the FDA for the same intended use and similar in technical characteristics, then the FDA only grants “clearance” (pre-market approval) to market the new substantially equivalent medical device on the market. Capillus laser devices were substantially equivalent to devices on the market and thus not a candidate for the FDA approval process.
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.