FDA Clearance

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: CapillusUltra (formerly the Capillus82), CapillusPlus (formerly the Capillus202), CapillusPro (formerly the Capillus272 Pro)

The Capillus family of laser therapy caps have been cleared by the Food and Drug Administration by 510(k) pre-market notification submission for the treatment of androgenic alopecia (AGA) and promotion of hair growth in males who have Norwood Hamilton classifications of IIa-V patterns of hair loss; and treatment of androgenic alopecia and promotion of hair growth in females who have Ludwig (Savin) Scale Classifications 1-II or frontal patterns of hair loss; 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 CapillusUltra (formerly the Capillus82)
    • Click to read about the FDA 510(k) clearance for the CapillusPlus (formerly 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
    • Click to read about the Capillus' FDA 510(k) clearance for CapillusX and CapillusX+ (formerly Capillus112 and Capillus244)

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.
 

Why do some medical devices and 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.

*See details of clinical trials at ClinicalTrials.gov
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