Class IIIb hand-held lasers are too dangerous for use as pointers or amusement articles. Furthermore, promotion of Class IIIb or IEC Class 3B products for pointing or amusement violates FDA requirements and United States law. Manufacturers of such products may be required to repair, replace, or refund the purchase price of violative products distributed in the U.S. These products are also subject to detention and seizure by the U.S. Customs and Border Protection when imported.
Irresponsible use of more powerful laser pointers poses a significant risk of injury to the people exposed. Persons who misuse or irresponsibly use lasers are open to personal liability and prosecution.
What are the FDA requirements for Class IIIa and IIIb laser systems.
Class IIIa or IEC Class 3R lasers can be dangerous. Class IIIa lasers can cause temporary visual effects such as flash blinding, which could distract or startle the person exposed. The risk of injury is very small when Class IIIa pointers are used responsibly because natural body motion of a person holding the pointer or motion of a person who might be exposed makes it difficult to expose the eyes for a long period of time. People also have a natural aversion to bright lights and are likely to close their eyes and turn their heads if exposed.