Get Back to Feeling Confident Again
Clinical Studies prove Capillus works
Backed by scientific research
After detailed and rigorous research from the National Institute of Health, LLLT has been confirmed as an effective solution to revitalize tissue regeneration - including new hair growth. Our technology is rigorously tested against our strict criteria for performance and safety, ensuring maximum results with minimal risks.
Capillus Laser Caps
Laser TherapyRead The Paper
Low-Level Laser Light Therapy (LLLT) for Treatment of Hair Loss
Cynatine HNSRead The Trial
A clinically proven ingredient that was found to decrease hair shedding and improve anagen and telogen hair growth phases.
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.
What's the difference between FDA approval and FDA clearance for medical devices and drugs?
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.
Capillus Devices FDA Clearance
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)
The Scientifically Proven Solution
No matter your gender, age, genetics or hair goals.
Dr. Daniel McGrath
“Capillus has been a game changer”
Dr. Samer Muala
“Capillus is superior to the other brands of caps out there”
Dr. Antonella Tosti
“This is something that is really helpful to reduce inflammation on the scalp”
The Science Behind Lasers
- Increase cell metabolism and health of the blood vessels in the scalp for thicker and more durable hair shafts.
- Stimulate the sebaceous glands for silkier-looking hair.
- Increase melanin production in the hair follicles, darkening gray hairs.
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