A comprehensive resource for safe and responsible laser use
Laserworld set up a special website, www.cdrh.info, with a statement and information from their viewpoint.
The International Laser Display Association published guidance for ILDA Members and others who are doing shows in the U.S. with Laserworld and RTI projectors.
FDA listed the following actions:
X-Laser LLC will bring into compliance:
1. All purchasers and associated dealers of affected LLS projector models will be notified by mail and email of their failure to comply with the performance standard. The notification will follow the format and include the information required by 21 CFR 1003.21. Those that do not respond within 14 days will be notified a second time. Those not responding to the second attempt will be notified again every 6 months for the next 2 years. Non-responsive dealers will be ineligible for future orders.
2. All affected LLS projectors will be repaired by removing the auto and music modes from the dipswitch accessible settings, after which, these modes will only be accessible through the DMX connection. These actions, including transportation of the LLS projector, will be made free of charge.
3. All LLS projector models that X-Laser receives, regardless of purpose, will be checked for dipswitch accessible auto or music modes and repaired if needed.
4.Corrective actions will be completed within 120 days of receipt of this letter.
For further questions please call (866) 702-7768.
For additional details from X-Laser, click the “read more” link. Click to read more...
On Dec. 22, 2017, Santajoy initiated a nationwide recall of Galaxy Holiday Laser Lights and Northern Lights Holiday Laser Lights. These laser projection products may incorporate a laser having a higher output than intended and fail to comply with FDA performance standard requirements (21 CFR 1040.10 and 1040.11). These higher-power lasers have the potential for eye injury.
Consumers who purchased any of the 5,254 units of Galaxy Holiday Laser Lights and Northern Lights Holiday Laser Lights sold by Walmart between August 1, 2017 and October 25, 2017 should stop using them and return them to any Walmart store for a full refund.
The Galaxy Holiday Laser Lights and Northern Lights Holiday Laser Lights were manufactured from May through September 2017 and distributed from August through October 2017. The affected products sold by Walmart can be identified by the packaging photos and UPC numbers shown below.
Santajoy voluntarily recalled these products after becoming aware that the product presented a potential safety hazard and has notified the FDA of this action. There have been no reports of injury related to the use of these products. Santajoy is notifying the public through this press release, and Walmart is accepting the return of these products for a full refund.
Walmart Stores Inc. distributed these products nationwide. Consumers with questions may contact Walmart via telephone at 1-800-Walmart from 7 a.m. to 9 p.m. CT Monday through Friday or online at www.corporate.walmart.com/recalls for more information.
Note: As of January 1 2018, neither laser was listed on the Walmart Product Recalls webpage. The product recall also did not appear to be at FDA’s recalls webpage or enforcement report webpage, as of January 1. The only online source on that date was the December 22 2017 Business Wire press release, or a few publications and news sources such as KCTV that reprinted the Business Wire press release.
FDA gave these examples of laser toys:
- Lasers mounted on toy guns that can be used for “aiming”;
- Spinning tops that project laser beams while they spin;
- Hand-held lasers used during play as “light sabers”; and
- Lasers intended for entertainment that create optical effects in an open room.
According to the Consumer Update, “Toys with lasers are of particular interest to the FDA because children can be injured by these products. Because they are marketed as toys, parents and kids alike may believe they’re safe to use.”
The FDA had tips for safe use, including:
- Do not aim at persons or animals
- Do not aim at any vehicle, aircraft or shiny surface; or persons playing sports
- Children’s toy lasers should be Class I.
- Children should not be allowed to own or use laser pointers. Pointers are not toys.
- Do not buy or use any laser that emits more than 5 milliwatts.
- See a health care professional in case of a known or suspected laser eye injury.
The FDA’s health warning was referenced in numerous news and publication sources over the 2017 holiday season.
From the FDA Consumer Update, “Laser Toys: How to Keep Kids Safe”. FDA also linked to a 2015 FDA YouTube video on laser pointer safety.
For background, LaserPointerSafety.com has a series of webpages about laser toys which begin with a summary here.
The SKY Technologies Blue Handheld includes a keyswitch, 3-5 second emission delay, remote interlock, and a shutter to cut off the beam, as required by FDA regulations enforced by the agency’s Center for Devices and Radiological Health (CDRH). Under current (May 2014) law, the laser appears to be legal for sale and use in the U.S., assuming the manufacturer also submitted a proper Laser Product Report and has filled all other FDA/CDRH import and paperwork obligations.*
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Although the agency did not give a reason, such bans have been imposed in other countries in response to climbing numbers of laser illuminations of aircraft as well as reports of eye injuries caused by higher-powered consumer lasers.
The proposal would not make it illegal to own or responsibly use portable, battery-powered lasers of 5 mW or more. However, manufacturers could not make or sell these into general commerce in the U.S.
The agency will accept comments for 90 days (until August 2 2014) on the new proposal. FDA will then review the comments. Based on whether it believes any objections or suggestions are valid, the agency could put the guidance into effect (thus imposing their new interpretation), could submit a revised proposal, or could withdraw its proposal.
What lasers are covered by the proposed 5 mW limit?
FDA does not have direct authority over battery powered portable lasers. For example, the words “pointer” and “handheld” laser do not appear in U.S. laser regulations 21 CFR 1040.10 and 1040.11.
Therefore, to regulate these lasers, the May 5 draft proposes an extension of the FDA’s existing authority to regulate surveying, leveling and alignment (“SLA”) lasers. In the May 5 proposal, FDA asserts that the existing definition of SLA lasers also can applied to lasers with the following design characteristics:
- Compact size (i.e. small, lightweight)
- Battery power
- Ergonomic design to permit hand-held use
- An aperture in the laser product's protective housing to transmit laser emission into open space
- Portability to permit use in open spaces or in unrestricted environments
- Features that utilize the laser’s straight line emission for surveying, leveling, or alignment
According to the FDA, these types of lasers would be affected by the new 5 mW limit:
- Laser pointers
- Tools incorporating laser guides
- Gun sights
- Target designators
- Night vision illuminators
- Visual disruptors
What lasers are NOT covered by the proposed 5 mW limit?
The FDA's proposed 5 mW limit would NOT apply to lasers with the following design characteristics:
- Predictable, stable power input and output
- High quality power supply and/or power conditioning components
- Adjustability of power and wavelength
- Design that facilitates remote actuation
- Hard wire connection to power mains
From the FDA’s Surveying, Leveling, or Alignment Laser Products - Draft Guidance for Industry and Food and Drug Administration Staff webpage, published online May 2 2014. This webpage includes the procedure for submitting comments to FDA.The FDA’s PDF version of the draft guidance document is here.
Editorial comment from LaserPointerSafety.com: We have previously published our opinion disagreeing with the FDA’s interpretation of “SLA” lasers. The existing regulations are clear on what constitutes “surveying, leveling or alignment” (SLA) lasers. While we understand the FDA’s intent, in our view, they are going about it the wrong way. They are essentially “making it up” by adding characteristics (size, battery power) which are in no way derived from the clear, existing definition of SLA lasers. As support of this position, we have not found any surveying, leveling or alignment lasers which look the same as the majority of laser pointers and handhelds. This topic is discussed in much greater detail on our page describing FDA authority over laser pointers and handheld lasers.
These regulations, 21 CFR 1040.10 and 1040.11, require laser product manufacturers only to self-certify to the Food and Drug Administration that their products meet safety standards. Once the FDA’s Center for Devices and Radiological Health reviews and acknowledges the certification, the laser product can be marketed in the United States.
UL is providing a third-party, independent check on the manufacturer’s claims. This can be provided to retailers such as Amazon.com which in August 2013 began requiring third-party verification of lasers sold on its website. UL can also assist with preparation of a manufacturer’s FDA report.
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FDA cites eight items of noncompliance:
- Three of these items relate to a January 2006 letter which FDA says Wicked did not respond to.
- Four items relate to Wicked claiming in 2006 and 2008 that its lasers were sold for surveying, leveling and alignment (SLA) purposes; FDA says Wicked is not complying with restrictions on SLA lasers. (FDA has greater authority to regulate SLA lasers than it does to regulate general-purpose lasers).
- The final item objects to Wicked stating on its website that its products are “FDA Certified” when in fact the manufacturer certifies compliance to FDA, who reviews and files the certification documents.
The restrictions will be lifted, FDA told Wicked, once “CDRH determines that you have established an adequate quality testing program, and you have submitted the required reports and report supplements.”
From Gizmodo. The full text of FDA’s warning letter to Wicked is after the link (click “Read more...”)Click to read more...
FDA is especially concerned about laser pointers above 5 mW, and about aircraft incidents. “In 2008, pilots reported a total of 950 cases of laser light striking an aircraft or illuminating a cockpit....The distraction from flash blindness could cause a serious accident.”
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