Caution: The following is an important safety message regarding low-level laser therapy and laser therapy caps.
How to Verify FDA Clearance
- 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 not been cleared by the FDA.
How to Verify Clinical Results
- 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.
- 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: Study Details, 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.