Lasers used for medical purposes must be approved by the U.S. Food and Drug Administration (FDA). The FDA regulates the safety and effectiveness of lasers used in medical applications, such as laser surgery, laser therapy, and laser-assisted diagnostics. In some states, 'medical purposes' includes laser hair removal. It also regulates the labeling and advertising of lasers used in medical applications. Manufacturers must submit a premarket notification to the FDA before marketing a laser device for medical use. The FDA reviews the premarket notification to ensure that the device is safe and effective for its intended use.