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  1. Alerts and Notices

Consumer Safety Alert: Internet Sales of Laser 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.

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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.

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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

Products should have a warning label (shown below) advising the user to avoid exposure to the laser radiation.

LASER Warning Label: Danger LASER Radiation Avoid Direct Eye Contact Maximum Output < 5mW Laser Diode 630-680 nm Class IIIa LASER Product

Consumers who can not verify the above, or do not understand what it means, probably should not sell or purchase the products.

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