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Nonmedical Lasers and Products that Contain LasersInformationDescription Products that use laser energy come in many sizes, shapes and forms. What they have in common is a laser which stores energy from a source, such as, an electrical discharge, chemical reaction or powerful optical illumination that releases the energy as light. Laser stands for Light Amplification by the Stimulated Emission of Radiation. One basic type of laser consists of a sealed tube, containing a pair of mirrors, and a laser medium that is excited by some form of energy to produce visible light, or invisible ultraviolet or infrared radiation. LEDs (Light Emitting Diodes) are different from laser diodes and are not subject to the Federal laser product performance standard. An ordinary source of visible light, like the sun or a light bulb, emits a mixture of invisible and visible light like waves. These waves have varying lengths and move in all directions. These differing “wavelengths” produce different types of light, such as ultraviolet, violet, blue, green, red and infrared. Unlike ordinary light, laser light has a specific wavelength and amplification of this specific wavelength results in a focused narrow beam of light that can be emitted in one direction. The amplification, focus, and directionality of this light concentrated in a small area can create a very high intensity light even at large distances from the laser. Uses
Risks/Benefits Laser products improve the quality, precision, accuracy, security and reliability of many forms of products, materials, communications and data handling. In order to realize the benefits of lasers, the risks of laser exposure must be managed. The biological effects of laser exposure can be predicted so that lasers can be placed in one of four major hazard categories called Classes. The risk of injury from lasers increases from Class I (non-hazardous) to Class IV (severe hazard).
There are laws, regulations, and standards that require engineering controls and risk communication to aid in the management of the biological hazards associated with each laser class. However, no controls are completely effective if lasers are improperly used. Laws, Regulations, & Standards 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 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, laser products must comply with radiation safety performance standards in Title 21 Code of Federal Regulations (Subchapter J, Radiological Health) Parts 1010 and 1040:
Manufacturers of laser products can request an alternate means of providing radiation safety; this is called a Variance: Laser products that are used for medical applications must also comply with the medical device regulations. For more information, see: Getting to Market with a Medical Device. Laser products designed and promoted for the production of laser light shows, displays, advertising, etc. are demonstration laser products subject to the requirements of 21 CFR 1040.11(c). For more information see: http://www.fda.gov/cdrh/radhealth/products/lasers-lightshows.html Industry Guidance CDRH provides guidance to laser manufacturers in the form of Laser Notices, Forms, and other documents. Submission/Reporting Forms CDRH provides reporting forms to laser manufacturers to assist them with preparation of product and other reports or submissions. Prepare your reports using either the CeSub Electronic Submissions software or the paper reporting forms listed below: If you want to submit using CeSub, you should start the FDA Electronic Submissions Gateway setup process now by following the instructions given on http://www.fda.gov/esg/ If you want to submit hard copies of reports, please follow the instructions below:
Other Guidance The FDA regulates radiation emitting products. Here are some useful links and documents in Portable Document Format (PDF) that are viewable with Adobe Reader:
Other Resources The Center for Devices and Radiological Health (CDRH) in the Food and Drug Administration works to protect public health, develops standards and regulations, enforces laws, and educates the public regarding lasers. These CDRH resources help consumers make informed decisions about lasers:
Updated March 3, 2009 |
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