FDA Warning July 30 2018
Update: Effective September 2018, after careful consideration and review of the community standard, we will resume offering the Valayza vaginal laser procedure using the Mona Lisa Touch laser, but only after the patient reviews and signs a new version of our informed consent document. Here is the entire informed consent document in pdf format. The FDA has not banned the procedure. They have issued a warning to laser manufacturers and doctors to present the facts to the patients and then let them use their own judgment. We completely agree. Click here for our full statement.