Caution: The following is an important safety message regarding low level laser therapy and laser therapy caps.
Not all laser therapy caps are created equally. Some are ineffective, and others are down right dangerous. Use caution when evaluating and purchasing laser therapy caps for hair loss treatment. Most dangerous are non-legitimate laser cap products found on eBay, Amazon, and other online shopping networks. Always purchase a laser therapy cap through an authorized physician reseller, and be wary of products that can be purchased online anywhere other than from a manufacturer who is registered with the US Food & Drig Administration.
This page has been created to help physicians and consumers separate fact from fiction when comparing popular laser therapy caps. To ensure safety and efficacy, consumers are warned to verify FDA clearance prior to the purchase and use of any product. Additionally, you can check to see if there have been clinical trials conducted on a product to verify its effectiveness.
Clearance from the United States Food and Drug Administration (FDA) demonstrates two important facts. First, it verifies the medical device manufacturer has submitted their documentation and any clinical trial results to support the product’s ability to safely perform as claimed. In addition, FDA clearance means the federal government has reviewed the device as an impartial 3rd party expert, and has deemed it to be at least as effective as marketed.
Prior to purchase, take the following steps to ensure the product has been cleared by the FDA:
Try it: The Capillus272 Pro laser cap’s 510(k) case number is: K143199. Visit the FDA online at Accessdata.fda.gov to search for our K Number and verify our FDA clearance.
Clinical trial results are the best way to gauge the safety and effectiveness of a medical device. If a manufacturer claims they have conducted clinical trials of their own, the trials must be registered and made available to the public in order to comply with the Safe Medical Device Act of 1996.
Prior to purchase, take the following steps to verify claims regarding clinical trials:
Try it: Visit ClinicalTrials.gov and perform a search for “Capillus.” In the search results, locate the study titled “A Novel Approach to Treating Androgenetic Alopecia in Females with Low Level Laser Therapy.” Follow the steps below to confirm our clinical trial results:
Take the first step toward a fuller, thicker, and natural head of hair. Visit the following page to locate an authorized Capillus physician in your area. If you are unable to locate a physician near you, we are happy to arrange a tele-consultation with a licensed hair restoration surgeon. To request a tele-consultation, call Capillus at 1-844-280-4680.