Is Theradome Safe? When was Theradome FDA Cleared?

The PRO was FDA cleared in June 2013 for women and the EVO was FDA cleared for women in May 2016. The Theradome PRO and EVO were cleared in January 2018 for men.

The purpose of the FDA clearance is to validate the safety and effectiveness of a medical device. To protect people from false claims and dangerous medical equipment, the United States requires rigorous testing that includes laboratory and clinical trials to prove both safety and effectiveness. Data derived from these studies, which must meet specific requirements, are submitted to the FDA via a 510(k) submission form for review and clearance to legally market the medical device.

An FDA 510(k) clearance allows consumers to distinguish between proof and false claims concerning safety and efficacy. Only after gaining clearance–the acknowledgment that the device is safe and effective for public sale–is an FDA 510(k) clearance granted to the manufacturers of a medical device. It is very important that any device you consider for purchase is FDA cleared. We advise you to visit the FDA.gov website to check for a product’s FDA compliance status before reaching a decision.

Our official FDA clearance letters can be seen on the FDA website at: