Lumina BlissLights Laser Safety Variance cdrh not required

The U.S. Safety Variance: What's Required?

Professionals who work with lasers know they can dazzle and entertain almost any audience in almost any
venue. But in the United States, manufacturers of lasers displays must overcome a hurdle not faced by other
lighting suppliers: the buyer’s fear of government required paperwork. This article examines the regulations
faced by a typical U.S. venue installing a laser. Following a few simple rules will not only satisfy federal reporting
requirements but make a display safer and more enjoyable.

In the United States, laser products are regulated by the Center for Devices and Radiological Health (CDRH),
a division of the Food and Drug Administration. The CDRH’s duty is to insure that the public is not harmed by
lasers that pose an eye hazard (and in some cases a skin hazard). The agency has formulated a straightforward
series of rules governing the use of lasers. Following these rules will keep customers from being exposed to
uncomfortable and potentially damaging levels of laser light while still allowing an impressive show to go on.

Managers of nightclubs and other venues should first know that lasers emitting less than 5 mW of light—called
Class IIIa lasers by the CDRH—do not require any paperwork. Until recently, these Class IIIa lasers were not
quite bright enough to satisfy all club patrons. But the recent introduction of low-cost, low-power YAG lasers that
produce a lime-green color may change all that. Because the eye perceives YAG-green as much brighter than
the red typically found in low-powered lasers, these Class IIIa YAGs allow club owners to bring truly attention-
getting laser effects to their site without federal paperwork requirements.As with virtually any laser source,
however, you should never shine even a 5 mW beam into the eyes of the audience. CDRH’s safety guidelines
require these low-powered beams to remain at least 2.5 meters above the floor at all times to prevent eye
exposure (higher-powered lasers must stay at least 3 meters above the floor).

Moving up to lasers above 5 mW, there are two documents that potential operators need to be aware of:
a Variance and the Laser Light Show Report. The CDRH grants a variance to use lasers for entertainment
purposes in return for the user’s pledge to follow safety guidelines. The Laser Light Show report is more
specific—it details how the laser installed at a venue complies with federal safety rules. Unless you are
experienced with laser equipment, it’s best to let a professional handle the initial paperwork.

Some companies process a purchaser’s variance application without charge, while others may charge
$500-$2,000, depending on the complexity of the display. Purchasers should investigate their options
before buying to determine what paperwork is included and what type of training a vendor offers. The end
user should receive basic training about federal safety rules. Venues, for example, must designate which
employee is their “safety officer” and file a brief annual report with the CDRH. The laser vendor should make
the purchaser aware of these and other simple requirements. After learning the basics, compliance with CDRH
rules should become a matter of routine.

Once a variance application has been submitted to the CDRH, it takes approximately 6-8 weeks to receive
the variance. Users should keep this lead-time in mind; without a variance, a laser can’t be used.

Potential laser users should read the CDRH handbook, “Laser Light Shows: Who’s Responsible,” a layperson’s
overview of safety, which can be downloaded at www.fda.gov/cdrh/radhlth/pdf/llsgde01.pdf

Other CDRH documents of available for download, including reporting guides and annual reports, can be found
at www.fda.gov/cdrh/comp/rad_consumer.html