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  1. Laser Products and Instruments

Important Information for Laser Pointer Manufacturers

What is the purpose of this document?

This document interprets 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. The document also discusses inappropriate use of high-powered, battery-operated, portable lasers.

How are laser products classified?

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.
  • 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):

“Surveying, leveling, or alignment laser product means a laser product manufactured, designed, intended or promoted for one or more of the following uses:

(i) Determining and delineating the form, extent, or position of a point, body, or area by taking angular measurement.

(ii) Positioning or adjusting parts in proper relation to one another.

(iii) Defining a plane, level, elevation, or straight line.”

Hand-held lasers promoted for entertainment purposes or amusement also meet the second definition, that of “demonstration laser products” as defined by 21 CFR 1040.10(b)(13):

“Demonstration laser product means a laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition.”

If a laser product is promoted for pointing purposes, either of these definitions can apply.

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.

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.

With any laser product, the potential for injury depends both on the product itself and how the product is used. Higher powered Class IIIb or IEC Class 3B lasers are dangerous and can cause either temporary visual effects or an eye injury.

What is the problem with more powerful Class IIIb lasers being promoted and sold as pointers?

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?

The FDA standard 21 CFR 1040.10 and 1040.11) requires a warning label on Class IIIa and IIIb products. 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.

Do other organizations have requirements or standards for lasers?

Yes. Several states have registration requirements and annual registration fees for operators of Class IIIb lasers. Check with the Department of Health in your state for additional information.

The American National Standards Institute (ANSI) publishes standards for the Safe Use of Lasers2:

  • Z136.1 American National Standard for the Safe Use of Lasers: 2000
  • Z136.5 American National Standard for the Safe Use of Lasers in Educational Institutions: 2000
  • Z136.6 American National Standard for the Safe Use of Lasers Outdoors: 2000

The ANSI standards contain procedures for avoiding exposure to laser light, designation of a Laser Safety Officer, training of operators, and the posting of warning signs in laser operating areas for Class IIIb lasers. People who operate Class IIIb lasers should be familiar with these standards to ensure the laser is used safely. In cases where a laser pointer is misused and results in an injury or alleged injury, authorities may refer to these standards as criteria for appropriate use and safety precautions.

Can battery-operated, portable laser systems be sold in the U.S?

Yes, battery-operated, portable laser systems can be sold in the U.S., providing that they fully comply with the standard, are certified and reported, and are not Class IIIb lasers sold or promoted for pointing or amusement purposes.

People who operate Class IIIb portable laser systems should be familiar with the above ANSI standards for safe use of lasers. This ANSI series of standards includes specific information for the safe use of such laser products in their applications of use.

1. IEC – International Electrotechnical Commission Standard 60825-1, Ed. 1.2: 2001-08

2. ANSI Z136 standards are available from the Laser Institute of America (www.laserinstitute.org)

 
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