A comprehensive resource for safe and responsible laser use

US: Review of 1-watt blue laser with US-required safety features

A USD $159 1-watt blue laser, apparently having all required FDA safety features, was reviewed by a gadget blog on May 4 2014.

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.*

skytech_bluelaser-diagram-400w


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US: FDA proposes defacto ban on selling pointers, handhelds above 5 milliwatts

The U.S. Food and Drug Administration on May 5 2014 will announce its intent to limit laser pointers and handheld lasers to be below 5 milliwatts. If adopted, this action would impose a defacto ban in the U.S. on the sale to consumers of portable, battery powered lasers of 5 mW or more. Currently, such lasers are available for sale in the U.S. at powers of up to 3 watts (3000 milliwatts) which is 600 times the proposed FDA limit.

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
  • Levels
  • 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
  • Non-portability
  • 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.

US: Underwriters Labs offers third-party testing for laser pointer sellers

Underwriters Laboratories announced on October 17 2013 that it will offer third-party testing of laser pointers for manufacturers and retailers. UL said this came in response to increasing laser pointer incidents and mislabeling. In February 2013, the National Institute of Standards and Technology reported that most laser pointers they tested were not in compliance with U.S. laser regulations.

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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US: FDA "disapproves" of Wicked Lasers; stops imports

Tech website Gizmodo reports that the FDA’s Center for Devices and Radiological Health (CDRH) sent a letter Nov. 3 2010 to Wicked Lasers, disapproving of “the quality control and testing program for all [Wicked] laser products.” This includes the well-known Spyder III Arctic, a nominal 1-watt, 445 nm blue handheld laser.

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.
FDA gave Wicked 15 days to respond in one of three ways: by refuting the charges, by requesting an exemption, or by notifying purchasers and taking corrective actions (e.g., a recall or refund). Wicked cannot certify lasers under the old “disapproved” testing program, and cannot import or sell non-compliant lasers or non-certified lasers.

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...

US: New FDA publication on laser pointer hazards

The U.S. Food and Drug Administration presented their views on the hazards of powerful laser pointers, in a webpage and in a downloadable PDF brochure. According to Cdr. Dan Hewett of the FDA’s Center for Devices and Radiological Health, “When used responsibly, lasers are safe. However, a powerful laser, used irresponsibly, is unsafe, particularly when misused as a toy or directed at people, vehicles or aircraft.”

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.”


FDA publication about laser pointer hazards

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