Medical lasers are medical devices that use precisely focused light sources to treat or remove tissues.
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).
Lasers are used in many types of surgical procedures. Some examples include
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.
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:
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:
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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