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capillus hair loss

Capillus Light Therapy Cap Featured in Modern Salon Magazine

Capillus Light Therapy Cap Featured in Modern Salon Magazine

Modern Salon magazine has featured Capillus LLC, during their annual HAIR + Summit live event dedicated to helping salon professionals provide their clients with solutions for hair loss and thinning.

The story focuses on how Capillus laser therapy caps play a major role for stylist and salon clients in the reversal of hair loss due to androgenetic alopecia.

The article, which appeared in the magazine’s online platform, highlights Capillus by stating: “In an intimate breakout session, Capillus shared details on their Stylist Program, offering their laser therapy caps designed to prevent progression of hair loss and regrow thinning hair.”

As Carly Klein, national educator for Capillus states in the article: “Up until recently, Capillus laser therapy caps were only cleared for sale by the FDA through medical professionals,” Klein continues, “Our Stylist Program means we can now be sold through salons and stylists, too.”

In addition to highlighting Capillus’s hair restoration efforts, this year’s HAIR + Summit featured the new comfortable flexible fit Capillus cap with continuous wave light delivery. This new advancement vastly reduces the users wear time from 30 minutes every other day to 6 minutes daily.

The new technology now provides users with a continuous wave output for a faster treatment. All Capillus mobile laser therapy caps are available for legal distribution by salons and stylists as per FDA clearance.

For a link to the article click here.

Readers are invited to visit https://www.capillus.com to learn more about Capillus hair regrowth products and laser therapy medical devices.

To learn more about the Capillus Stylist Program visit https://www.capillus.com/stylists.

About Capillus, LLC

Capillus, LLC offers prescription and over-the-counter hair regrowth products and medical devices for both men and women suffering from hair loss. The Capillus premiere product lines include low-level laser therapy (LLLT) devices that are FDA-cleared and manufactured in the US under the highest-quality certification standard for the medical device industry (ISO13485).

Capillus also offers additional non-prescription clinical hair products for hair and scalp health. Capillus products are available directly to the public for at-home use and also to their network of physicians for office use. For more information visit http://www.capillus.com.

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Capillus82 Laser Therapy Cap

Does the NAD’s Capillus Decision Contradict the FDA

Does the NAD’s Capillus Decision Baldly Contradict the FDA?

On September 12, the NAD released its decision in its review of the Capillus82 hair growth device (Case #6107).  This case is unusual in that it addressed a challenge to a prescription-only medical device, and related closely to the FDA’s clearance of that product to be marketed.

The NAD took pains to emphasize that its decision did not contradict the device’s FDA-cleared indication for use, but did it really?

First, a little background on how the FDA treats medical devices of this kind.  Low-to-moderate-risk medical devices may be marketed without preapproval through what is known as the 510(k) clearance process.

Instead of being evaluated and approved by the FDA for safety and efficacy, the device can be “cleared” if it is “substantially equivalent” to a device that already is legally marketed.

The existing “predicate device” may itself have undergone full approval, or it too may be a 510(k) cleared device pointing to a yet earlier predicate device.

The device maker’s 510(k) submission must convince the FDA that the new device is technologically equivalent to the predicate device or is otherwise substantially equivalent in safety and effectiveness.  The intended use must be the same as that of the predicate device.

The process has been analogized to a generic drug approval predicated on chemical equivalence to an existing branded drug.

The Capillus82 is a hat with 82 laser diodes lining the inside.  Its intended use is to treat androgentic alopecia (i.e., slow hair loss) and promote hair regrowth in men and women having certain kinds of pattern baldness.

It received FDA 510(k) clearance in January 2017, with the predicate devices being the Hairmax Lasercomb and the iGrow II – no, I am not making these up – which used different form factors to apply laser light to the head, something that apparently promotes hair growth.

Clearance was applied for and granted on the basis that the Capillus82’s technology was the same as those of the Lasercomb, iGrow and other laser hair growth treatments, with minor differences that should have no impact on safety or efficacy.

capillus 82The NAD started this matter based on its own market surveillance, investigating the Capillus82’s claims that it was “clinically proven to regrow hair” and “prevent progression of hair loss,” among others.  Capillus proffered no clinical trial data on the Capillus82 to support these claims.  After all, the whole point of 510(k) clearance is to show technological equivalence to a predicate product, thus demonstrating efficacy to the FDA, without having to do trials on the new device.

But because the new device itself was not tested, NAD found Capillus’ claims unsubstantiated and recommended that they be discontinued.  In the key sentence of the decision, NAD wrote, “While the advertiser established to the FDA’s satisfaction that the Capillus82 is substantially equivalent to other devices cleared by the FDA to promote hair growth and, as a result, it can be marketed for its intended use, the cited studies are not a good fit to support the challenged claims that Capillus82 is clinically proven to regrow hair.”  Even without the establishment-claim language, the NAD added, studies on other products are “not a good fit to support the claim that Capillus laser therapy caps prevent progression of hair loss and regrow thinning hair.”

The NAD similarly recommended discontinuation of Capillus’s claim that the Capillus82 has “no known side effects,” because these claims were not supported by tests on the actual product.

Again, Capillus had relied on substantial technological equivalence to predicate products to establish Capillus82 as being safe, as well as effective, in its 510(k) submission.

So, is this a bald rejection of the FDA’s clearance process?  The NAD opened its decision by claiming deference to the regulatory authority and later wrote, “nothing in the decision prevents Capillus from making claims about its product which are consistent with its FDA clearance for indications of use, i.e., to treat androgenetic alopecia and promote hair growth in men and women with specific patterns of hair loss and skin types.”  But, to borrow a finance expression, the NAD’s explanation has some hair on it.

The claim of which NAD disapproved – “Capillus laser therapy caps prevent progression of hair loss and regrow thinning hair” – seems a straightforward statement of the product’s key benefit, consistent with its FDA-cleared indication for use.

The FDA cleared Capillus to market the Capillus82 with no disclosure of any side effects, evidently satisfied that there were none to disclose – yet the NAD considered the affirmative statement of no known side effects unsubstantiated.

Can Capillus say nothing about its product other than a dry repetition of its FDA indication language?  If the NAD is right that neither the basic benefit nor the lack of side effects is substantiated, should the product even be on the market?  It would seem that the whole premise of FDA 510(k) clearance – that clinical evidence of the safety and efficacy of Device A is transferable to substantially equivalent Device B – was rejected by the NAD.

This case serves as a heads-up to marketers of 510(k)-cleared medical devices that the NAD may regard clinical testing on the actual product as necessary to go beyond merely being permitted to market the product by making affirmative benefit claims for it, even if those benefit claims seem to be implied by the FDA’s clearance of the device.

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Does the NAD’s Capillus Decision Contradict the FDA

Capillus New Design of Laser Therapy Caps

Capillus New Design of Laser Therapy Caps

Capillus New Design of Laser Therapy Caps

Capillus, LLC has announced the redesign of their FDA-cleared low-level laser (light) therapy (LLLT) caps that treat hereditary hair loss. The new Flexible Fitting Design offers a more comfortable, adaptable fit and is available for purchase immediately.

Carlos Piña, CEO of Capillus, LLC is delighted with the improvements to the home-use laser therapy caps intended to improve both user experience and hair regrowth.

“Our customers spoke, we listened,” said Piña in a recent video announcement. “We strive every single day for continuous improvement and work hard to maintain our premier level of manufacturing quality and customer satisfaction. Our customers help shape our products and the future of Capillus.”

All newly sold caps, including the Capillus82™, Capillus202™ and Capillus272™ Pro, will include the revamped interior with the same acclaimed laser technology trusted by physicians worldwide.

The caps also feature auto-programmed treatment sessions within the battery pack so users don’t have to track their wear time manually.

New Capillus Cap Design Features Flexible Fit for User Comfort

Capillus New Design of Laser Therapy Caps
Low-level laser (light) therapy (LLLT) is one of the few safe and effective treatments for genetic-based hair loss. Patient compliance is always a deciding factor in its efficiency.

This new design allows each cap to adapt to most scalps comfortably. A better fit encourages consistent patient use and optimal hair regrowth results. Unlike rigid materials or helmet devices, Capillus laser therapy caps are designed to adapt to the user.

The clinical trial for Capillus laser therapy was recently published in the June edition of Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery.

Capillus laser caps offer excellent laser light density and were only available by prescription until earlier this year when they gained FDA clearance for over-the-counter sale. With three different home-use models to choose from, individuals suffering from androgenetic alopecia have an array of options to suit their needs.

For general information about Capillus products, or for physicians interested in joining Capillus’ international physician network visit http://www.capillus.com.

About Capillus, LLC

Capillus, LLC offers prescription and over-the-counter hair regrowth products and medical devices for both men and women suffering from hair loss. The Capillus premiere product lines include low-level laser therapy (LLLT) devices that are FDA-cleared and manufactured in the US under the highest-quality certification standard for the medical device industry (ISO13485).

Capillus also offers additional non-prescription clinical hair products for hair and scalp health. Capillus products are available directly to the public for at-home use and also to their network of physicians for office use.

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capillus

Published Clinical Study Shows Capillus Laser Therapy Safe and Effective at Treating Female Androgenetic Alopecia

Published Clinical Study Shows Capillus Laser Therapy “Safe and Effective” at Treating Female Androgenetic Alopecia

A peer-reviewed study authored by Dr. Shelly Friedman, D.O., F.A.O.C.D. and supported by Patricia Schnoor, BSBA, confirms that low-level laser therapy (LLLT) with Capillus® may play a considerable role in the treatment of androgenetic alopecia for females, given the impartial evidence illustrating favorable hair regrowth results.

The research was published in the June 2017 edition of Dermatologic Surgery, the official journal of the American Society for Dermatologic Surgery, encouraging familiarity of LLLT as a practical method of fighting hair loss at home within the greater medical community.

Dr. Friedman of the Scottsdale Institute for Cosmetic Dermatology is a board-certified hair restoration surgeon with nearly three decades of experience treating over 15,000 patients with hair loss.

Patricia Schnoor is the head of quality assurance and governmental affairs at Capillus, overseeing the assembly, testing and quality control for Capillus’ line of FDA-cleared at-home laser caps.

The study’s circulation is expected to pave access to new international markets, allowing more individuals to undergo laser therapy hair loss treatment by way of physician prescription or recommendation.

“Performing and publishing clinical research under the rigor of a prestigious journal is of critical importance for doctors prescribing under evidence based practice guidelines,” said Fernando Bermúdez, Director of International Distribution at Capillus. “Published data is also a reference for increasingly savvy consumers wanting to make an educated purchase decision before committing to a long-term treatment.”

The purpose of this randomized controlled trial was to outline the effects of photobiomodulation, or laser light, on the hair follicle and surrounding tissues in patients suffering from hair loss. The subjects consisted of 44 healthy females ages 18 to 60 years who were recruited at two separate board–approved treatment sites.

The Capillus272™ Pro was used in the study under the alias of a “handi-dome” laser device. Using the discreet dome insert with laser diodes operating at 650 nm, active participants receiving LLLT with the Capillus272 Pro™ showed a 51 percent mean increase in hair counts compared to patients who used a seemingly identical yet defunct device.

The researchers concluded that low-level laser treatment administered for 30 minutes every other day for 17 weeks is both safe and effective in treating androgenetic alopecia in healthy females between the ages of 18 to 60 with Fitzpatrick skin Types I to IV and Ludwig–Savin Baldness Scale I-2 to II-2 baldness patterns.

No side effects or adverse reactions were reported by any subject at any time during the study.

For more, view the published abstract on Dermatologic Surgery, June 2017 – Volume 43 – Edition 6.

About Capillus

Capillus proudly offers hair regrowth products and medical devices recommended by hair restoration physicians around the world for both men and women with hair loss.

Capillus’s premiere product lines include low level laser therapy (LLLT) devices that are FDA-Cleared and manufactured in the USA under the highest quality certification standard for the medical device industry (ISO13485).  Capillus272 Pro, Capillus 202, and Capillus82 are light-weight and battery-operated laser therapy caps for at-home hair loss treatment, used 30 minutes every other day and worn discreetly under a sports cap.

The Capillus272 OfficePro is for laser therapy sessions administered in salons and clinics for clients seeking introductory treatment.  Capillus laser therapy devices feature more lasers than any other FDA-Cleared clinical device on the market for non-presrciption sale. Capillus offers additional products for clinical hair therapy and scalp health as well as keratin hair fibers for temporary concealment of thin hair. Readers are invited to visit http://www.capillus.com to learn more about Capillus hair regrowth products and laser therapy medical devices.

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Capillus Laser Cap

Michigan Hair Surgeon Now Providing Capillus® Laser Cap to Hair Loss Patients

Michigan Hair Surgeon Now Providing Capillus® Laser Cap to Hair Loss Patients

A new, mobile low level laser therapy (LLLT) product has arrived at Accents Cosmetic Surgery to help men and women prevent the progression of hair loss.

Called the Capillus272 Pro™, this wearable laser therapy product is designed to increase the flow of blood and natural growth factors directly to hair follicles, helping patients who suffer with androgenetic alopecia develop a thicker and fuller head of hair.

“I highly recommend the Capillus272 to all of my patients who are in the market for a low-level laser light therapy device,” says Dr. Mark Berkowitz, founder of Accents Cosmetic Surgery. “It is simple to use, it has science behind it, and it’s something that I believe in and use myself.”

Capillus-LLLT-Device-Hair-Regrowth-Receives-FDA-Clearance

Capillus272 Pro™ is cleared by the FDA for the treatment of androgenetic alopecia, or hair loss, in men and women.

The laser cap has been shown to promote up to 51% increase in hair count, according to independently reviewed clinical studies available online at ClinicalTrials.gov.

Compared to other low level laser therapy options, Capillus272 Pro™ offers patients a high degree of discretion and convenience. The laser insert is placed beneath the cap of an ordinary hat or head covering, allowing patients to enjoy treatment without the worry of prying eyes. Capillus272 Pro™ is battery-operated and comes with a complimentary carrying case, allowing for consistent use around the house, at the office, and even on vacation.

“Compliance is very important for low level laser light therapy,” Dr. Berkowitz explains in a video interview. “If you aren’t going to use it, it’s never going to work. Well with a cap, it is so easy. I put it on, I drive to work with it 3 times a week or I watch TV with the cap on. If you use the Capillus®, it will work for you.”

In addition to low level laser therapy with Capillus272 Pro™, Dr. Berkowitz offers a variety of surgical and non-surgical hair restoration options for men and women who suffer with hair loss.

Dr. Berkowitz specializes in the NeoGraft hair transplant procedure, having performed hundreds of procedures totaling over 1.4 million grafts in the Michigan area.

For more information on hair restoration with Capillus272 Pro™, visit http://www.accentscosmeticsurgery.com.

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