Because they are medical devices, surgical laser products must also comply with the medical device regulations. For more information, see Getting to Market with a Medical Device.

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Manufacturers of surgical laser products are responsible for compliance with all applicable requirements of Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1000 through 1005:

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As with any type of surgery, laser surgery has potential risks. Risks of laser surgery include incomplete treatment of the problem, pain, infection, bleeding, scarring, and skin color changes.

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Laser surgery uses non-ionizing radiation, so it does not have the same long-term risks as x-rays or other types of ionizing radiation.

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In addition, surgical lasers must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010, 1040.10, and 104.11:

The term “laser” stands for Light Amplification by Stimulated Emission of Radiation. Ordinary light, such as that from a light bulb, has many wavelengths and spreads in all directions. Laser light, on the other hand, has a specific wavelength. It is focused in a narrow beam and creates a very high-intensity light. Because lasers can focus very accurately on tiny areas, they can be used for very precise surgical work or for cutting through tissue (in place of a scalpel).

Manufacturers of electronic radiation emitting products sold in the United States are responsible for compliance with the Federal Food, Drug and Cosmetic Act (FFDCA), Chapter V, Subchapter C - Electronic Product Radiation Control.

On Oct. 1, 2024, the FDA began implementing a reorganization impacting many parts of the agency. We are in the process of updating FDA.gov content to reflect these changes.

With proper use, lasers allow the surgeon to accomplish more complex tasks, reduce blood loss, decrease postoperative discomfort, reduce the chance of wound infection, and achieve better wound healing.