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, 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 & Drug 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.
How to Verify FDA Clearance
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:
- Request the FDA 510(k) case number. This is a unique number assigned to each product that is cleared by the FDA. If the retailer (physician) is unable to provide it, request the contact information of the device manufacturer. Then, contact the manufacturer directly to request the 510(k) number. If you are unable to find a 510(k) case number, the product has likely not been cleared by the FDA.
- After obtaining a 510(k) case number, visit the FDA at the following URL to verify its authenticity: Accessdata.fda.gov.
- After navigating to the link above, enter the 510(k) case number in the search database. Then, click ‘Search.’
- Review the results to ensure the 510(k) case number matches the manufacturer name and product name. If you are unable to match the 510(k) case number with both the manufacturer and product, the product has bot been cleared by the FDA.
Try it: The CapillusPro 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.
How to Verify Clinical Results
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:
- Visit ClinicalTrials.gov.
- Locate the search box below the subheading, “Search for Studies”
- Enter the company name and click “Search.”
- Review the search results to cross reference published studies with the claims made by the manufacturer.
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:
- To view the study, click on the title (for your convenience, we have provided the link here).
- Within the body of the page, you will see 3 main tabs: Full Text View, Tabular View, and Study Results. Click on Study Results.
- On the Study Results tab, scroll down to the Outcome Measures section.
- Beneath the Outcome Measures section, click on the link that reads Show All Outcome Measures (for your convenience, we have provided the link here).
- In the Measured Values table, locate the line item that reads Percentage Increase in Terminal Hair Counts from Pre-Treatment.
- In the far left column, note the results of the study agree with claims made by our company in all print and digital media: Capillus LLLT handi-dome laser demonstrated a 50.9% increase in terminal hair counts among study participants.
Locate an Authorized Capillus Laser Cap Physician
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.