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U.S. Department of Health and Human Services

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Does FDA regulate these new powerful laser "pointers" and are they hazardous?

FDA regulates all laser products, even handheld, battery-powered lasers that are available for purchase FROM manufacturers, importers, assemblers, dealers or distributors in the United States and its territories. This includes lasers manufactured or obtained on a continuing basis for the purpose of sale or resale.

FDA requires that manufacturers of these lasers limit the power of the laser light to 5 milliWatts (often abbreviated as "mW") or less. The labeling or packaging must allow the purchaser to know the power of the laser, its hazard class, and its wavelength before the laser is purchased. Even online advertisements must display this information for the purchaser.

Even the smallest handheld, battery-powered lasers are capable of emitting laser light at hazardous powers. Larger models, the size of a small flashlight, can burn skin and pop balloons. More importantly, consumers should assume any size handheld battery-powered laser they do not directly control has the potential to blind or permanently affect eyesight.

One way to determine if such a laser has been manufactured to regulatory power and hazard class limits is to find labeling. The labeling that comes with the laser (and online labeling) must display the power, hazard class, and wavelength. The wavelength is a number that describes the color of the beam.

The label must display the laser power. It must be 5 milliWatts or less. The label must display the hazard class. It must be Class I, Class IIa, Class II, Class IIIa or Class 1, Class 2 or Class 3R.

REMEMBER:

  • Do not purchase a handheld, battery-powered laser labeled with hazard Class IIIb, Class IV, Class 1M, Class 2M, Class 3B or Class 4 unless the manufacturer has an approval from FDA (called a "variance") to allow the purchase. Lasers approved for purchase in these classes often have very specific uses and may be sold under certain conditions known to the manufacturer. Sales without a variance, or sales that violate the conditions of the variance, ARE ILLEGAL.
  • No laser, no matter what class or power, should be pointed at the eyes or reflected into the eyes from a mirror surface. No laser, no matter what class or power, is safe to shine at the operator of aircraft, watercraft, or vehicles.
  • Laser light remains powerful and bright many miles or kilometers from the laser.
  • Unlabeled lasers or lasers you do not control should be assumed dangerous, too powerful for most intended consumer uses, and could damage your eyesight from a momentary direct or indirect exposure to the beam.
  • Handheld, battery-powered lasers have power and class limits for a reason; to prevent eye and skin damage. Laser light can damage eyesight in less time than you can blink or look away. Do not assume lasers offered for sale as "approved" or "safe" are not hazardous.
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