U.S. FDA certified laser class how to divide

The FDA regulates the release of radiation from electronic products for the Federal Food, Drug and Cosmetic Act, Title V, sections 531-542 (FEDERAL FOODDRUG AND COSMETIC ACT, referred to as the FD& C). The so-called radiation releasing electronic products, including TV antennas and screens, microwave ovens, diagnostic X-ray equipment and the use of X-ray or laser-related products (such as optical drives and laser pointers (laser pointer)). Most electronic products that emit radiation are not recognized as medical devices, but if the manufacturer or distributor claims that the product has a medical function, the product must comply with the FDA's specifications for medical devices. The main reason for Congress to regulate electronic products that emit radiation is to prevent the health effects caused by the use of such products by consumers. In the case of laser-related products, for example, optical drives, which are the mainstay of our exports, are required to comply with FDA regulations, and products containing optical drives, such as notebook computers, are also regulated.

Classification of laser products:

Class I laser products are not biohazardous. Any beam that may be viewed is shielded and the laser system is interlocked during laser exposure.

Class II laser products have an output power of 1 milliwatt. Will not burn skin or cause fire. Since eye reflection prevents some eye damage, these lasers are not considered hazardous optical devices.

Class IIIa laser products have an output power of 1 milliwatt to 5 milliwatts. They do not burn the skin. Under certain conditions, this type of laser can cause blindness as well as other damage to the eyes.

Class IIIb laser products have an output power of 5 milliwatts to 500 milliwatts. At higher powers, these lasers are capable of burning the skin. These laser products are clearly defined as hazardous to the eyes and will cause eye damage, especially at higher power levels.

Class IV laser products have an output power greater than 500 milliwatts. This type of laser product is definitely capable of causing eye damage. Like burning skin and igniting clothing, lasers are capable of igniting other materials.

The FDA-approved categories of laser products include: laser pointers, laser presentations, laser displays, products containing laser units (CD players, DVDs, CD-ROMs, laser printers, etc.), safety protection, and rescue products.