Contour Light is a Class II medical device, and a 510K is required for marketing.

Contour Light: FDA 510K202955

As is required for FDA clearance, the Contour Light has been fully tested by an independent testing facility and studied by an Independent Review Board (IRB) verifying that it meets multiple requirements as stipulated by the FDA, including electrical functionality and safety under temperature and humidity conditions plus numerous additional benchmarks.

The Contour Light IRB (Independent Review Board) clinical study is registered with: clinicaltrials.gov #NCT 04451824.

FDA Clearance allows Contour Light to legally make specific claims of significant inch loss, pain relief and increased blood circulation that informs the general public of what this system can and does provide in terms of treatment outcomes.