The US Food and Drug Administration has issued a safety alert regarding certain types of display lasers used in entertainment.
Laser projectors manufactured by Laserworld USA, Inc., Laserworld (Switzerland) AG, and Laserworld (ASIA) Co Ltd (hereafter Laserworld), are designed to generate visual effects for the purpose of demonstration, entertainment, advertisement, or artistic composition using high-powered lasers. This includes projectors labelled as Ray Technologies International GmbH (RTI).
These high-powered laser products are commonly used at night clubs, concerts, and outdoor light shows and may expose members of the public, performers, and operators to potentially harmful laser radiation. The FDA has determined that this safety information applies to Laserworld Class 3b and Class 4 laser projectors distributed since 2008.
FDA recommendations for light show manufacturers
The FDA is recommending that entertainment venues and other laser light show manufacturers stop using Laserworld and RTI Class 3b and Class 4 laser projectors because they lack required safety features that protect the user and the general public from harmful exposures to high-powered laser radiation. Missing features can include a manual reset mechanism and remote interlock connector.
The FDA discovered through sample testing and reviewing manufacturer-provided user manuals that multiple Laserworld laser projector model series were lacking required safety features, did not function in a safe manner, and were lacking important user information.
Since September 2013, the FDA has worked with and taken action against Laserworld to improve their safety. In the past, the company has requested what is termed “variance” (FDA approval that allows a manufacturer to deviate from a required performance standard). This was denied. Laserworld’s efforts to address the FDA’s safety concerns have been incomplete and not sufficiently addressed.
Laserworld’s manufacturing facility in Lake Mary, FL was inspected by FDA. The inspection determined that Laserworld’s quality testing program was ineffective and incapable of certifying that their products comply with the federal performance standard for laser products.
Before the inspection could be completed, Laserworld closed the Lake Mary location. Laserworld failed to complete corrective actions, did not notify affected persons, and failed to submit an acceptable corrective action plan concerning Club Series laser projectors. They also continued to certify and market Class 3b and Class 4 laser projectors without an FDA approved variance. The FDA is concerned that users of Laserworld projectors are unaware of the following:
- Many Laserworld and RTI Class 3b and Class 4 lasers projectors do not comply with the applicable Federal performance standards.
- Laser light shows that use noncompliant Laserworld or RTI laser projectors are potentially dangerous and prohibited under Federal law.
- Laserworld and RTI laser projectors that do not have a variance are not compliant with Federal performance standards. They cannot be used in laser light shows before a variance is obtained from the FDA.
- Laserworld and RTI cannot certify, demonstrate, or otherwise introduce or deliver for introduction into commerce, or import Class 3b and 4 laser projectors until they obtain an approved variance from the FDA.
Actions to take
The FDA recommends that those who purchased Laserworld laser projectors, including RTI laser projectors, stop using them immediately. In addition, potential customers should refrain from purchasing Laserworld / RTI Class 3b and Class 4 laser projectors.
The FDA will continue to work with Laserworld A.G. to bring these products into regulatory compliance and will keep the public informed if significant new information becomes available.
PLASA recognises that the requirements in the USA are different to those of the UK and Europe, but operators of these types of lasers are urged to ensure they satisfy themselves that the laser being used does meet the correct standards and is safe to use in the application it will be used in.