The FDA has two types of regulatory requirements for manufacturers of medical devices to protect the public. It requires only that the manufacturer give 90 days notice of its intention to market a device. As long as the device is shown to be similar to other devices already on the market, the FDA allows the device to be marketed. To make specific claims of safety and effectiveness, manufacturers are required to submit only very limited supporting scientific evidence. Laser is Safe The long-term safety of laser hair removal devices has not been established, because there have been only a few, brief, clinical trials prior to their introduction onto the market.
Some clinics require patients to sign a consent form.
If in doubt get legal advice. Since electrolysis results are permanent, and laser results are temporary, it is impossible for laser treatments to be more cost-effective than electrolysis. Laser hair removal is more properly compared with other temporary methods. These devices are new, and treatments are expensive - costing thousands of dollars for even small areas od the body. For Additional Information . . .