As with the other types of patient labeling, be sure to ask the surgeon for the patient labeling for the specific laser device being used. Some lasers have been cleared for medical uses such as removing tissue. Because heat from lasers cauterizes blood vessels, there is less bleeding compared to scalpel use. If you wish to learn whether a specific laser has been cleared for a specific indication, you may contact FDA's Consumer Staff. You will need to provide the name of the manufacturer and the specific product name of the device before contacting the Consumer Staff.
Medical lasers are prescription devices available for sale only to licensed practitioners.
You should check with your state medical licensing board to determine who qualifies as a licensed practitioner in your state. The Office of Compliance has issued notifications and warnings to firms suspected of illegally marketing these devices with claims of effectiveness. Please note that FDA law and regulations contain provisions that permit limited distribution of unapproved devices for use in clinical investigations. There are numerous clinical investigations being conducted in this and other countries to determine safety and efficacy with these devices for the intended uses that are proposed. Even with IRB approval, a sponsor must comply with IDE requirements such as monitoring investigations, maintaining records, making reports, and complying with prohibitions on promotion and commercialization of investigational devices.