we sell capillus laser hair restoration products
capillus 312 laser device
- We will match the Original LaserCap 224 Pro price with study participation!
- 88 more lasers at no additional cost
- Only 6 minutes per day.
- Free Shipping in the U.S.
- Patients must agree to provide progress photos every 4 months for 1 year as part of our ongoing study to receive this offer.
- FDA Cleared & Made in the U.S.
- Capillus 312 PDF
How Capillus Works
Capillus laser therapy is a physician-recommended, FDA-cleared treatment clinically proven to regrow thinning hair and prevent further progression of hair loss due to androgenetic alopecia (pattern balding). For only 6 minutes of use per day, Capillus laser therapy caps utilize safe, low level lasers to stimulate, energize, and renew cells within the hair follicle for thicker, healthier hair.
Low level light treatment is an option that has been used for those who are suffering from male & female pattern hair loss. Laser red light has been shown to be effective in stimulating and energizing the cells within the hair follicle.
Laser Therapy: An Established Science
In 1966, Hungarian physician Endre Mester first published an experiment in which he observed accelerated hair growth in rats treated with laser therapy, making alopecia the first legitimate therapeutic indication for laser therapy. Recently LLLT (low-level laser treatment) has gained acceptance in treating hair loss as evidence from clinical trials and successful patient cases have validated the therapy.
Though it has been used for over a decade… in the last few years, low-level light therapy has finally gained mass acceptance by the foremost physicians in the field of hair restoration, including world-renowned physicians who are both leaders and members of prestigious industry organizations such as the American Board of Hair Restoration Surgery and the International Society of Hair Restoration Surgery.
Low-level light therapy (LLLT) has been used since the 1960s to treat various medical conditions such as alopecia, chronic ulcers, and chronic pain, headaches, musculoskeletal, and neuropathic pain without major adverse side effects. Each of these applications is based on the biological effects of photobiomodulation in living organisms. The use of low levels of visible or near-infrared (NIR) light for reducing pain, inflammation and edema, promoting healing of wounds, deeper tissues and nerves, and preventing tissue damage has been known for almost forty years since the invention of lasers1.
A multitude of fields of medicine have applied the science of phototherapy using low-power laser to their professions:
- Physical therapists: to treat a wide variety of acute and chronic musculoskeletal aches and pains
- Dentists: to treat inflamed oral tissues and to heal diverse ulcerations
- Dermatologists: to treat edema, non-healing ulcers, burns, and dermatitis
- Orthopedists: to relieve pain and treat chronic inflammations and autoimmune diseases
- Veterinary Medicine
- Sports Medicine and Rehabilitation Clinics: to reduce swelling and hematoma, relieve pain, improve mobility, and treat acute soft-tissue injuries.
LLLT and the Management of Hair Loss
Low-level light therapy was first approved by the Food and Drug Administration in 2007 for the treatment of mild to moderate male pattern hair loss for a laser comb device designed to re-grow hair. The problem with a laser comb device is that it is not practical in application, which leads to improper adherence of instructions for use and thus less than optimal results in non-clinical use. The emergence of the Capillus laser therapy cap revolutionized the use of
LLLT for hair loss using red light lasers has been reported to:
- Increase cell metabolism and the health of blood vessels in the scalp for thicker, supple and more durable hair shafts
- Stimulate the sebaceous glands for silkier-looking hair
- Increase melanin production in the hair follicles, darkening gray hairs.
LLLT for Hair
In recent years, hair restoration has been a leading field in which the application of LLLT technologies have enabled physicians to improve patient outcomes. Whether used in conjunction with hair transplant procedures or prescription hair loss medications, laser hair therapy has the potential to significantly improve the health of the hair follicle, leading to a fuller and more natural looking head of hair.
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.
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 & 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