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FDA Laser Laws

The Food and Drug Administration (FDA) is an agency of the United States government. The FDA regulates food safety, drugs, medications and medical devices. FDA laser laws regulate most lasers manufactured in the United States, as well as lasers that are imported into the country.

  1. Registration

    • Pursuant to Title 21 of the Code of Federal Regulations (CFR) §1040.10, all manufacturers of lasers are required to send a listing of all laser products, including product model numbers, laser wavelengths, laser medium and product names, to the Director of the Office of Compliance Center for Devices and Radiological Health. FDA laser laws require laser manufacturers to maintain and to permit access to all sales and shipping records related to laser sales. Low level lasers that do not cause harm to human health do not require registration with the FDA, as long as these products are labeled properly.

    Labeling

    • Lasers are divided into classes based upon their potential damage to human health. According to Title 21 CFR §1040.10, FDA lasers laws require all manufacturers of Class IIa and II lasers to include, on a label affixed to the laser product, the following words: "Avoid Long-Term Viewing of Direct Laser Radiation." Class IIIa and IIIb lasers must include the name "Class IIIa laser product", as well as the following words: "LASER RADIATION -- DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS." Class IV lasers are more powerful than lower classes and can even damage the skin. Labels on a Class IV laser must include the following warning: "LASER RADIATION -- AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION." Signs around a Class IV laser must be posted to warn of the dangers of radiation exposure.

    Measurements

    • According to Title 21 CFR §1040.11, the FDA requires all Class III and Class IV lasers to include a way to measure the radiation output of the medical laser. The margin of error cannot be more than 20 percent when the device is fully calibrated. Instructions must be provided by the manufacturer on how to calibrate the laser. This rule does not apply to lesser-powered lasers which are used in medical treatments, as long as these lasers are not used on the eye.

    Approval

    • Any laser medical device used to treat humans must receive approval from the FDA. FDA laws cover lasers used in hair removal, tattoo or blemish removal, treating acne scars and removing tooth decay. FDA laser laws also cover eye surgery, a process known as photorefractive keratectomy (PRK) and LASIK (Laser-Assisted In-Situ Keratomileusis). For new laser treatment products, clinical trials have to be conducted before approval, and the FDA may require audits of clinical studies.

    Violations

    • Any unlabeled or unsafe lasers imported into the U.S. may result in the loss of the manufacturer's accession number, a number given by the FDA to the manufacturer to allow it to legally import lasers. Improper or illegal use of lasers is considered medical malpractice, and the offending physician may be civilly and criminally sued by the FDA, in addition to having her medical license revoked.

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