FDA > CDRH > Radiological Health Program > Products and Procedures > Surgical and Other Medical Lasers > Consumer Safety Alert: Internet Sales of Laser Products

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 laser pointers. Overpowered green 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 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. Medical lasers may only be sold to licensed medical practitioners.
2. 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. Laser products that are advertised as uncertified components may only be sold to other manufacturers and may not be sold to the public for general use.
3. Laser products should have certification and identification labels (shown below) stating the product complies with the federal laser standard.
   

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

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

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

Contact FDA

If you have any questions about a laser product you are considering offering for sale or purchasing on the internet, contact FDA's Center for Devices and Radiological Health at 240-276-0326.

You can also report web sites that you suspect are illegally selling laser products online at http://www.fda.gov/oc/buyonline/buyonlineform.htm.

For More Information

FDA provides general information about buying regulated products online at http://www.fda.gov/oc/buyonline/default.htm.

FDA warns against purchasing potentially illegal or recalled pharmaceuticals or medical devices on the eBay web site at http://cgi3.ebay.com/ws/eBayISAPI.dll?ViewUserPage&userid=usfda

FDA has also issued the document: "Important Information for Laser Pointer Manufacturers".

Updated January 12, 2006