Laser Pointers and the Law

This page explains some of the many FDA regulatory requirements as they apply to laser pointers, explains the power limits for these products, and the applicable requirements for information for safe use and for promotional materials. We are limiting the content of this page to that concerning laser pointers.

 Lasers are generally classified according to the hazard posed by the amount and type of light they emit. Hazard classes range from Class I to IV with Class I lasers being non-hazardous and Class IV lasers being the most hazardous.

Class I products include laser printers and CD players where the laser radiation is usually contained within the product. Products exceeding Class I permit access to some amount of laser radiation.
Class II and IIa products include bar code scanners.
Class IIIa products include laser pointers.

NOTE: The lasers we sell are Class IIIa laser pointers
Class IIIb and IV products include laser light shows, industrial lasers, research lasers.
What is a laser pointer?
Laser pointers are hand-held lasers that are promoted for pointing out objects or locations. Such laser products can meet one of two definitions for laser products. The first is for “surveying, leveling, and alignment laser products” as defined by Title 21 of the Code of Federal Regulations (CFR) Section 1040.10(b)(39):

Does FDA have a mandatory limit on the power emitted by laser pointers?
Yes. Laser products promoted for pointing and demonstration purposes are limited to hazard Class IIIa by FDA regulation.

21 CFR 1040.11(b) and 1040.11(c), limit surveying, leveling, and alignment, and demonstration laser products to Class IIIa. This means that pointers are limited to 5 milliwatts output power in the visible wavelength range from 400 to 710 nanometers. There are also limits for any invisible wavelengths and for short pulses. Pointers may not exceed the accessible emission limits of CDRH Class IIIa or IEC1 Class 3R.

NOTE: The lasers we sell are limited in power to 5mW.

Are Class IIIa laser pointers dangerous?
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.

What are class IIIb lasers and are they dangerous?
Lasers that emit between 5mW and 500mW output power are in Class IIIb or IEC Class 3B. Class IIIb lasers cannot legally be promoted as laser pointers or demonstration laser products. Product labels and user instructions must describe the hazard classification of the product and its output characteristics.

Class IIIb products must also have a key switch and connector for remote interlock. The products are also required to have identifying and certifying labels and instructions for safe use.

NOTE: Any laser pointers you see advertised that claim to be more than 5mW and do not have removable key switches and shutters are illegal in the USA and many other countries.  We have never seen a legal one advertised.