Does the FDA allow laser devices to be sold online?

When browsing for laser devices online there are numerous sites selling the products. However, it is essential to ensure that you are buying a laser device which fully corresponds with federal safety requirements. Such lasers may not be legally appropriate for sale, or certain devices may only be appropriate for individuals who have the correct professional licence to use them.


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What to be aware of

If you are buying replacement parts, you do not need to be a manufacturer. However, it is crucial that the parts come with an official statement which classifies the complete laser product. It is additionally vital that the statement details the correct installation instructions and the manufacturer. Laser components which are not replacements can only be bought by manufacturers. Surgical lasers require a licence and you cannot legally purchase one without one.

All laser devices should have the correct certification and warning labels which clarify their authenticity and the licensing needed for their purchase. When devices are identified as Class IIIB or Class IV, you must be in possession of an approved laser light show variance from the FDA in order to buy one. Any unlabelled devices are considered dangerous and unfit for purchase by the FDA.

Action taken by the FDA

If a device is found to be illegal then it will be denied entry into the USA. When discovered inside the USA, efforts will be made to ensure that illegal laser devices are returned to the manufacturer or destroyed. To prevent such situations from taking place, the FDA is constantly regulating the level of radiation present in devices to make sure that they are safe for customer use. Understandably, this requires careful consideration by businesses both manufacturing and buying the devices. However, there are plenty of companies to help with FDA 510k such as

The FDA additionally takes the misuse of guidelines in manufacturing very seriously and takes action to prevent unsafe lasers from being sold. Overpowered green, blue and violet lasers are a major concern when found in distribution. This is due to the unsafe modification of their radiation levels since manufacture.

Going forwards

You can legally purchase a laser device online as long as you are correctly licensed for the device and have ensured that it is genuine and safe.

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