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

• Components of audio, video and computer equipment such as CD, DVD, Blue Ray, HD (High Definition), or other optical disk players and recorders
• Many bar code readers
• Printers, copiers, FAX machines
• Laser pointers and pens commonly used for presentations, surveying, and positioning
• Fiber optic systems for telephone, video, and computer networks.
• Applied to material processing operations such as cutting, welding, engraving, or marking systems.
• Applications in laboratories for research, measurements, and optical sources.
• Lasers specifically designed for use in medical procedures.
• Lasers specifically designed and promoted for laser light shows, entertainment, advertising, etc. 

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.

Laser Hazard Classes

The FDA recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser is and the greater the potential to pose serious injury if used improperly. The labeling for Classes II–IV must include a warning symbol that states the class and the output power of the product. Roughly equivalent IEC classes are included for products labeled under the classification system of the International Electrotechnical Commission.

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.

What is a laser?

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.

There are many different types of lasers and each uses a different type of laser medium. Common laser media include gases such as argon or a helium and neon mixture, solid crystals such as ruby, and liquid dyes or chemicals. When energy is applied to the laser medium, it becomes excited and releases energy as particles of light (photons).

A pair of mirrors at either end of the sealed tube either reflects or transmits the light (see illustration below) in the form of a concentrated stream called a laser beam. Each laser medium produces a beam of a unique wavelength and color.

Laser

What are lasers used for?

Lasers are used for a variety of purposes including pointing out objects during a presentation, aligning materials at construction sites and in the home, and by doctors for cosmetic and surgical procedures. Many items you encounter on a daily basis use lasers, including CD and DVD players; bar code scanners; dental drills; laser-guided tools, such as levels; and laser pointers.

Why are lasers uniquely hazardous?

Two characteristics of laser light contribute to the hazard:

• Laser light can be emitted in a tight beam that does not grow in size at a distance from the laser. This means that the same degree of hazard can be present both close to and far from the laser.
• The eye can focus a laser beam to a very small, intense spot on its retina, which can result in a burn or blind spot.

What do you mean by laser “radiation?” Does it go through the body or cause cancer?

Some lasers emit radiation in the form of light. Others emit radiation that is invisible to the eye, such as ultraviolet or infrared radiation. In general, laser radiation is not in itself harmful, and behaves much like ordinary light in its interaction with the body. Laser radiation should not be confused with radio waves, microwaves, or the ionizing x-rays or radiation from radioactive substances such as radium.

Are all lasers legal for consumer use?

No. Some lasers are strictly for use by medical, industrial, or entertainment professionals and should only be used by a person with appropriate training and licenses.

The FDA requires labels on most laser products that contain a warning about the laser radiation and other hazards, and a statement certifying that the laser complies with FDA safety regulations. The label must also state the power output and the hazard class of the product. Consumer laser products are generally in classes I, II, and IIIa, while lasers for professional use may be in classes IIIb and IV.

What do the different classifications of lasers mean?

Laser Hazard Classes

The Food and Drug Administration (FDA) recognizes four major hazard classes (I to IV) of lasers, including three subclasses (IIa, IIIa, and IIIb). The higher the class, the more powerful the laser and the potential to pose serious danger if used improperly. The labeling for Classes II–IV must include a warning symbol that states the class and the output power of the product. Approximate IEC equivalent classes are included for products labeled under the classification system of the International Electrotechnical Commission.

What are laser pointers?

Laser pointers are tools used for pointing out objects or locations, and are defined as "surveying, leveling, and alignment laser products" in an FDA regulation. They are commonly used during lectures and astronomy presentations, and laser pointers incorporated into spirit levels and hand tools are also very popular. In recent years laser pointers have become readily available, and are commonly sold in hardware, pet, hobby, and office supply stores.

Are laser pointers safe?

When used properly lasers pointers pose minimal risk if they meet laser power limits. Laser pointers are misused when they are directed at the eyes or treated as toys. The light energy from a laser pointer aimed into the eye can be more damaging than looking directly into the sun. In addition, the startling effect of a bright beam of light aimed at someone driving a car or operating other machinery can cause serious accidents.

The FDA is concerned about the increased availability of a variety of laser products that may be used unsafely. Green, blue and violet laser pointers have the agency particularly concerned. While there are legitimate uses for these laser pointers, they may be altered to become more powerful and unsafe if not used responsibly.

Is the brightness of the laser light a good indicator of its power and eye hazard?

No. Never assume the color brightness of a laser beam indicates its power.  In lighted conditions (indoors or outdoors), a beam from a powerful laser can appear to be the same brightness or dimmer than the beam of a less powerful laser. For example in the photo below, the green laser beam appears much brighter than the red and far brighter than the blue.  These are actually equally powered lasers and all three present the same eye hazard from looking into the beam. If you see a bright blue or violet laser beam with brightness similar to a green laser, you can safely assume that the blue/violet laser light is far more powerful and looking directly into the beam will cause severe and immediate eye damage.

As a rule, you should never look directly into any laser beam.

What is the proper use of a laser pointer?

Remember, laser pointers are not toys and they should only be used by an adult, or with adult supervision.

• Never aim or shine a laser pointer at anyone.
• Only activate the laser pointer when you are using it to point at a nearby object.
• Do not buy laser pointers for your children. Lasers are not toys.
• Before purchasing a laser pointer, make sure it has the following information on the label:
  • a statement that it complies with Chapter 21 CFR (the Code of Federal Regulations)
  • the manufacturer or distributor's name and the date of manufacture
  • a warning to avoid exposure to laser radiation
  • the class designation, ranging from Class I to IIIa. Class IIIb and IV products should be used only by individuals with proper training and in applications where there is a legitimate need for these high-powered products.

What is FDA’s role in regulating lasers?

The FDA regulates both medical and non-medical lasers. The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with federal standards or that have radiation safety defects. The agency also may test laser products and inspect displays of laser light shows to ensure the public is protected. Producers of laser light shows are required to tell the FDA where they are planning a show so that the agency can inspect it if possible and take action if required.

FDA is currently working to identify manufacturers of overpowered green laser pointers and other illegal lasers, and is taking action to prevent these unsafe products from being sold in the United States.

Medical lasers are medical devices that use precisely focused light sources to treat or remove tissues.

The term “laser” stands for Light Amplification by Stimulated Emission of Radiation. Ordinary light, such as that from a light bulb, has many wavelengths and spreads in all directions. Laser light, on the other hand, has a specific wavelength. It is focused in a narrow beam and creates a very high-intensity light. Because lasers can focus very accurately on tiny areas, they can be used for very precise surgical work or for cutting through tissue (in place of a scalpel).

Procedures

Lasers are used in many types of surgical procedures. Some examples include

• Cosmetic surgery (to remove tattoos, scars, stretch marks, sunspots, wrinkles, birthmarks, spider veins or hair)
• Refractive eye surgery (to reshape the cornea in order to correct or improve vision as in LASIK or PRK)
• Dental procedures (such as endodontic/periodontic procedures, tooth whitening, and oral surgery)
• General surgery (such as tumor removal, cataract removal, breast surgery, plastic surgery and most other surgical procedures)

Risks/Benefits

With proper use, lasers allow the surgeon to accomplish more complex tasks, reduce blood loss, decrease postoperative discomfort, reduce the chance of wound infection, and achieve better wound healing.

As with any type of surgery, laser surgery has potential risks. Risks of laser surgery include incomplete treatment of the problem, pain, infection, bleeding, scarring, and skin color changes.

Laser surgery uses non-ionizing radiation, so it does not have the same long-term risks as x-rays or other types of ionizing radiation.

Lasers and laser projection systems are used with other optical equipment, such as projection screens, mirror balls, remote projector heads, and fiber optics, to produce colorful, dramatic displays for entertainment purposes.

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. Ordinary light, such as that from a light bulb, has many wavelengths and spreads in all directions. Laser light, however, has a specific wavelength. It can be focused into a tight beam and can concentrate very high-intensity light at large distances from the laser.

Uses

• Music events
• Restaurants and Nightclubs
• Theatrical events
• Meeting venues
• Permanent light shows
• Laser effects with a fireworks display
• Art and advertising displays
• Laser video projection systems
• Artistic and entertainment lighting displays

Risks/Benefits

When used in the proper setting and handled by qualified professionals, laser light shows can provide dramatic displays and as backdrops to other entertainment and venues.

While the lasers themselves can cause injuries, laser light shows that are produced in accordance with FDA regulations keep hazardous lasers away from the audience. For shows where the laser beam could fall on the crowd, the power of the laser is kept below levels know to be hazardous.

Risks from improperly handled lasers include:

• Eye injury
• Skin burns
• Fire
• Other safety risks for pilots, drivers and others who may be distracted or temporarily unable to see

Instructors use them to draw attention to information on slide shows. Astronomers use them to point out stars, planets, and other heavenly bodies. And construction workers use them to level and align pipes.

These are all legitimate uses of laser pointers, says the Food and Drug Administration, which regulates lasers and other radiation-emitting devices. But the agency is concerned about the misuse of these potentially dangerous devices and their increased availability for purchase on the Internet.

Laser pointers are misused when they are directed at people or treated as toys. The light energy from a laser pointer aimed into the eye can be more damaging than staring directly into the sun. And the startling effect of a bright beam of light can cause serious accidents when aimed at a driver in a car, a pilot in a plane, or even a person holding a cup of hot coffee. According to the Laser Institute of America, one woman reported how other mothers she knew bought laser pointers for their children so they could imitate Star Wars characters Luke Skywalker and Darth Vader.

"Laser pointers have become consumer novelty products and promoted as toys," says Jerome Dennis, a consumer safety officer for the FDA's Center for Devices and Radiological Health (CDRH). "They're hazardous as toys and shouldn't be used frivolously."

The agency is concerned about the increased availability through the Internet of a variety of laser products that may be illegal or unsafe. Some laser products are intended for use only by professionals or other trained operators. And green laser pointers have the agency particularly concerned. While there are legitimate uses for these green pointers, they may be altered to become more powerful and unsafe if not used responsibly.

"These overpowered pointers may have been modified to emit more radiation than the manufacturer's original product," says Lt. Cmdr. Sean Boyd, M.P.H., head of the electronic products branch in CDRH, "and they are not compliant with our standard." The FDA sets safety standards that must be met before laser products, including pointers, can be legally sold in the U.S. market.

"The potential for injury increases as you increase the power output of the product," adds Boyd. "Certainly the potential for distraction or flash blindness or startling increases as well when you're talking about an overpowered green pointer."

Flash blindness is a temporary loss of vision that occurs when the eye is suddenly exposed to intense light--even from an unintentional sweep of laser light across a person's eyes. The effect can last from several seconds to several minutes. Recent reports of flash blindness in pilots from laser lights beamed at aircraft have further heightened the agency's concerns.

The FDA is working to identify manufacturers of overpowered green laser pointers and other illegal laser products and will take action to prevent these unsafe products from being sold in the United States.

FDA's Authority

The FDA has the authority to regulate all kinds of lasers. Under the Medical Device Amendments to the Federal Food, Drug, and Cosmetic Act, the agency regulates lasers used in medicine. And under the Electronic Product Radiation Control Provisions of the act, the FDA regulates both medical and nonmedical lasers such as those used to solder circuits in factories, to scan groceries in a supermarket, or to entertain a crowd with a light show in the night sky.

The FDA may inspect manufacturers of laser products and require the recall of products that don't comply with federal standards or that have radiation safety defects. The agency also may test laser products and inspect displays of laser light shows to ensure the public is protected. Producers of laser light shows are required to tell the FDA where they are planning a display so that the agency can inspect it if possible and take action if required. In 1995, the FDA, working with the Federal Aviation Administration, issued a moratorium that remains in effect on outdoor laser light shows in and near Las Vegas. The action, which affects Clark County, Nev., was taken after airline pilots reported experiencing temporary visual impairment during flights into or out of the county's three airports.

The FDA requires that labeling on most laser products contain a warning about radiation and other hazards and a statement certifying that the laser complies with FDA safety regulations. The label must also state the power output and the hazard class of the product.

The FDA recognizes four major hazard classes (I to IV), including two subclasses (IIIa and IIIb), of lasers--ranging from those that pose no known hazard to those that pose serious danger if used improperly. The higher the class, the more powerful the laser. Class I laser products, for example, include laser printers and CD players, which are not considered hazardous because the laser radiation is contained within the product.

Class IIIb and class IV laser products are very powerful and permit ready access to the laser radiation, which can cause eye or skin injury. Research and industrial lasers and laser light show projectors fall into these classes. Class IIIb and class IV laser light show projectors may be sold only by or to individuals or firms that have obtained approval from the FDA.

Buyer Beware

In addition to potentially harming your health, some high-powered pointers can damage your wallet, says Dennis. Consumers who purchase an illegal laser product on the Internet--whether knowingly or unknowingly--may lose their money if the product is manufactured outside the United States, he says. "There is a reasonable risk of having a charge laid against your credit card for goods you're not going to receive because they're going to be blocked by U.S. Customs and Border Protection."

What Consumers Can Do

1. Never aim or shine a laser pointer at anyone.
2. Don't buy laser pointers for your children.
3. Before purchasing a laser pointer, make sure it has the following information on the label:
   • a statement that it complies with Chapter 21 CFR (the Code of Federal Regulations)
   • the manufacturer or distributor's name and the date of manufacture
   • a warning to avoid exposure to laser radiation
   • the class designation, ranging from Class I to IIIa. Class IIIb and IV products should be used only by individuals with proper training and in applications where there is a legitimate need for these high-powered products.

The Food and Drug Administration (FDA) is aware that some laser products being sold on the internet may not meet federal safety requirements and should not be available for purchase by the general public. In some cases, these products are overpowered and may be unsafe if not used responsibly. In other cases, these products are intended for use only by licensed medical professionals, trained operators, or other approved users.

FDA’s Concerns

FDA is concerned about recent reports of laser products directed at aircraft—a potentially hazardous situation. The agency is particularly concerned about the increased availability of overpowered green, blue and violet laser pointers. Overpowered green, blue and violet laser pointers are those that may have been modified to emit more radiation than the manufacturer’s original product.

What FDA Can Do

FDA’s authority is over the manufacturers of laser products. These products must meet a federal standard for the amount of radiation they can emit and must be properly labeled. FDA is working to identify manufacturers of overpowered green, blue and violet laser pointers and other illegal laser products and will take action to prevent unsafe products from being sold in the United States. If illegal products are imported into the U.S., they may be refused entry, returned to the seller, or destroyed.

Buyer Beware

FDA recommends that consumers be cautious when buying laser products over the internet. Consumers may unknowingly purchase an illegal laser product or may lose their money if the illegal product is refused entry into the U.S. or destroyed.

Consumers should be aware that:

1. Surgical lasers may only be sold to licensed practitioners.
2. Laser components may be sold only to manufacturers unless they are also replacement parts. Replacement parts may be sold to any purchaser, but the part must include a statement that identifies the complete laser product in which it is intended to be installed and the manufacturer of the complete laser product so that the purchaser can obtain safe installation instructions.
3. Class IIIb and class IV laser light show projectors, identified as such on the label, may only be sold by or to individuals or firms with current, approved laser light show variances from FDA.
4. The brightness of a laser beam does not always indicate its relative power or potential for injury in comparison to other color laser beams. Powerful blue or violet lasers will appear less bright in comparison to equally powerful red laser beams and much less bright in comparison to equally powerful green laser beams.
5. A blue or violet laser beam that appears as bright as a red or green laser is very likely to be a powerful laser that can cause immediate eye damage. Blinking or looking away when exposed directly to the beam may not provide sufficient protection to avoid injury to the eye.

Laser products should have certification and identification labels stating the product complies with the federal laser standard.

• Complies with 21 CFR 1040.10 and 1040.11
• Complies with 21 CFR Chapter 1, Subchapter J
• Manufactured or distributed by...
• Date of Manufacture