U.S. LASER LAWS - A GUIDE FOR LDI EXHIBITORS

This page has been developed by ILDA and Laser Compliance, Inc. to help exhibitors at the LDI trade show.

LDI’s 10-page Laser Safety Requirements are here. This page exists to give additional information and links.

Information on this page is up-to-date as of July 5, 2017.

Information elsewhere on this ILDA website, or at other websites, may conflict with the information on this page. However, LDI EXHIBITORS SHOULD REFER PRIMARILY TO THE INFORMATION ON THIS PAGE because it is the most up-to-date and relevant for LDI exhibitors.

Links to the various FDA forms are in the text and also at the bottom of the page.
Summary of U.S. federal requirements
Laser products manufactured or imported into the U.S. are regulated at the federal level by the Food and Drug Administration (FDA) Center for Devices and Radiological Health (CDRH). The term “laser product” can refer to both the laser device/projector (hardware), and a laser display/show (how the hardware is used).

FDA has detailed information about their requirements here. The summary below lists the most important points as they relate to a trade show such as LDI, and to laser light show devices/projectors and displays/shows. The information is NOT necessarily valid for medical, surveying, industrial, or some other laser types.

FDA LASER EQUIPMENT (HARDWARE) REQUIREMENTS

Lasers and laser products which will be exhibited in a functioning manner (i.e., they will be powered on) must be certified as per FDA requirements. Class 3B and 4 laser display devices/projectors also must be varianced.

For all laser products:

     1. The manufacturer self-certifies that the laser product meets FDA requirements; particularly those described in 21 CFR 1002, 21 CFR 1010, 21 CFR 1040.10 & 21 CFR 1040.11, and/or FDA Laser Notice 50. Additional information is available in FDA Publication 86-8260, “Compliance Guide for Laser Products.” The manufacturer can “self-certify”; they do NOT need to use a third party such as Underwriters Laboratories.

     2. The manufacturer then reports this product to FDA using Form 3632, “Guide for Preparing Product Reports on Lasers and Products Containing Lasers,” commonly known as the “laser product report.”

     3. After submitting the laser product report, the manufacturer tests the product to confirm compliance with the information in the laser product report. Upon confirmation, the manufacturer affixes a certification label to the laser product. This indicates to purchasers, regulators and others that the manufacturer has certified the product, and has reported the product to FDA. (This can be a separate label, or can be text added to other required labels such as the Warning Label. Sample text is: “Complies with 21 CFR 1040.10 and 1040.11” or “Complies with 21 CFR 1040.10 and 1040.11, except for deviations pursuant to Laser Notice No. 50, dated June 24 2007.”)

For Class 3B and 4 laser display devices/projectors:

     1. Follow step 1 above.

     2. Follow step 2 above but do NOT follow step 3.

     3. A “variance” is also required. (This gives “permission to vary” from FDA’s requirement that only Class 1, 2 or 3R (IIIa) lasers be used for laser displays or shows.) All Class 3B or Class 4 laser devices/projectors intended for use in laser displays or shows must be manufactured and certified under the conditions of an approved FDA variance. Apply for the variance using FDA Form 3147, “Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display, or Device”, and submit this at the same time as the laser product report in step 2 above.

     4. FDA will review the documents. If FDA is satisfied, they will send a variance approval letter to the manufacturer. This letter specifies the certification label’s verbatim text. The certification label shall be affixed onto the laser device/projector.


FDA LASER DISPLAY AND SHOW REQUIREMENTS

Laser displays and shows are also “demonstration laser products” under FDA regulations.

  • Displays/shows using Class 1, 2 and 3R do not require a variance.

Note that both the device/projector (the laser product) and the display/show (how the laser product will be used) use Form 3147 to submit information to FDA. The difference is in item 7b, “Product for which a variance is requested”:
  
Stacks Image 112
  
The product in item 7b can be laser hardware (items 1 and 2), it can be a show using lasers (item 3) , or “other” (item 4). For a laser hardware manufacturer who also will be doing displays/shows, multiple boxes can be checked; for example, items 2 and 3.
  
FDA AND LDI NON-FUNCTIONAL PRODUCT REQUIREMENTS

Laser products which will be exhibited in a non-functional state (i.e., shall not be powered on at any time) may be exhibited without being certified. FDA requires each non-certified laser product displayed in public to carry a clearly visible label indicating “This laser product sample is not yet certified to U.S. FDA safety standards and cannot be activated.”

Note that LDI is additionally requiring that non-certified laser products must be disabled so they cannot be activated at the trade show.


FDA IMPORTATION REQUIREMENTS

All laser products coming from outside the United States must be declared upon import, and be accompanied during shipping by FDA Form 2877, “Declaration for Imported Electronic Products Subject to Radiation Control Standards.”

  • Certified laser products — those that have received an Accession Number from FDA — may be imported under Declaration B1 (complies with performance standards and has Accession Number).

  • Non-certified laser products imported into the U.S. under Declaration C2 in the form (temporary import bond for a trade show/demonstration) are allowed entry under the conditions of a bond. This is necessary to ensure they are not operated, and that they are promptly re-exported.
U.S. state and local requirements
Some U.S. states and localities have their own lasershow-related requirements.

As an exhibitor, you need to meet any requirements for the state, county and city where the LDI trade show is located.

See this page for more information.

Detailed laser safety information and U.S. federal requirements

IMPORTANT: The information below applies to laser products used for laser displays and shows. Specifically, it applies to “demonstration laser products” as defined in 21 CFR 1040.11(b)(13). The information also concentrates on exhibiting such laser products at a trade show, such as LDI.

While much of the information may also apply to other laser products — general purpose lasers, industrial, research, medical, surveying, etc. — some of these products may have fewer, different or more requirements. So use the information below only as a guide to laser display equipment and shows.

The information is presented to the best of ILDA and the authors’ knowledge. We are not responsible if information changes, or if FDA policy differs from what is listed here.
     
Laser classes
The following is a quick review of the major Classes (not including 1M and 2M). Some additional details about Classes are here and here.

Classes can be referred to by the old style Roman numerals I, II, IIIa, IIIb, and IV which are often found in FDA documents. We are using the newer style IEC Arabic numerals 1, 2, 3R, 3B and 4. Note that FDA IIIa is essentially the same as IEC 3R.

  • After each Class, we have listed the power levels for the kind of lasers typically used in laser display devices and projectors: small source, continuous wave (CW) lasers emitting small diameter, collimated visible beams. If you have some other type of laser product – for example, a laser with a non-visible beam, with a highly divergent beam, or with a pulsed beam -- consult a laser safety expert to determine the proper Class.

Class 1: Not considered hazardous. For typical display devices/projectors, 0 – 0.39 milliwatts (mW). No variance or other special requirements for displays/shows.

Class 2: Not considered hazardous for momentary viewing. Do not stare into beam. For typical display devices/projectors, 0.4 – 0.99 mW. No variance required for display/shows; however, do not use where persons could stare into, or have prolonged exposure into the eye.

Class 3R (FDA Class IIIa): Exceeds the exposure limits for momentary viewing, but is considered low risk. Avoid direct eye exposure. For typical display devices/projectors, 1 – 4.99 mW. No variance required for displays/shows. Can be used unattended if aimed into an area where a person’s eyes would normally not be expected to be located (such as behind a table or barrier). Can have laser light on persons if 1) the light is below the applicable Maximum Permissible Exposure and 2) the laser usage is continuously monitored.

  • When used for a laser display or show, Class 3B and 4 devices must be varianced to FDA. See the section “Obtaining a variance” (below) for details.

Class 3B: Can be hazardous when directly viewed by the eye. Avoid exposure to beam. For typical display devices/projectors, 5 – 499.9 mW.

Class 4: Can be hazardous to the eye from viewing direct or scattered light. Can be hazardous to skin. Avoid eye or skin exposure. Can be a fire hazard. Avoid exposing surfaces which could smolder or burn. For typical display devices/projectors, 500 mW and above.
Maximum Permissible Exposure
The Maximum Permissible Exposure (MPE) is the greatest amount of laser light that is permitted, under specified conditions. Said another way, it is the power or energy density that is not expected to cause damage to a specified structure (eye or skin), given a specified time of exposure.

The MPE varies depending on many factors:
  • The laser output power
  • For pulsed lasers, the pulse repetition rate
  • The laser wavelength
  • The time of exposure
  • The structure that could be harmed (different MPEs for eye and skin exposure)

Lasers used in displays and shows usually have similar characteristics: a small source, continuous wave (CW) emission, visible light, and small diameter beams that are collimated or weakly divergent.

For such lasers, the eye exposure MPE that is most commonly used is for unintended (inadvertent, accidental, unwanted) exposures of less than 0.25 second. Laser safety regulations are based on a person exposed to bright light who turns away, blinks or takes other aversion action within 1/4 second.

For the CW laser type specified above, and an exposure of less than 1/4 second, the eye exposure MPE is 2.54 milliwatts per square centimeter.

At the LDI trade show, lasers with accessible beams or effects will not be allowed over this MPE.

MPE for audience scanning

The 2.54 mW/cm² is for a static (non-moving) beam, where the aversion response limits the time exposed to the beam. The MPE allowed for audience scanning can be different.

For example, in the U.K. and some European countries, a peak irradiance of 1 mW/cm² is mandated. This more conservative limit is based on possible beam overlaps, and exposures longer than 0.25 seconds.

In the U.S., variances for FDA-approved audience scanning should state the maximum permitted MPE.
Definition of "demonstration laser product"
FDA regulates laser products (hardware containing lasers). They also regulate three laser uses: Demonstration, Medical, and Surveying/Leveling/Alignment.

Under 21 CFR 1040.10(b)(13) a laser display, show or demonstration is a “laser product”. Here is the definition:

  • “Demonstration laser product means any laser product manufactured, designed, intended, or promoted for purposes of demonstration, entertainment, advertising display, or artistic composition. The term ‘demonstration laser product’ does not apply to laser products which are not manufactured, designed, intended, or promoted for such purposes, even though they may be used for those purposes or are intended to demonstrate other applications.”

This FDA definition means that merely demonstrating a laser product at a trade show does not necessarily turn the product into a “demonstration laser product”. For example, a manufacturer of a general purpose laser product could (safely!) demonstrate the laser emitting a beam. One way this could be done is by enclosing the beam in a clear plastic tube, thus preventing human access.

Only if the laser product’s purpose is “demonstration, entertainment, advertising display or artistic composition” as defined above, then the laser product is a “demonstration laser product.”

Class 3B and 4 demonstration laser products are required by FDA to have an approved variance for the product (the device/projector) and an approved variance for the display/show (how it is used), prior to any public use such as exhibiting at LDI. These may be separate variances, or a single variance obtained by a manufacturer to cover both their device/projector and how it is displayed/showed.
Stacks Image 217
A general purpose Class 4 ion laser. Demonstrating how this works at a trade show does NOT make it a “demonstration laser product.”

However, if this laser is used for a “demonstration, entertainment, advertising display or artistic composition” as defined by FDA then it becomes a “demonstration laser product.” Because demonstration laser products are limited to Class 3R, using this higher-powered Class 4 laser for a show would require the user to apply for, and receive, a variance (FDA Form 3147) permitting use as a laser show device.
Regulation of lasers “introduced into commerce”

In general, if you are using a higher powered laser projector outside of your home, you must get permission from the U.S. Food and Drug Administration. You may also be subject to state regulation, such as needing a permit, a laser operator’s license and/or having to register your laser projector.

FDA Laser Notice 51, “Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors” requires anyone who is “introducing into commerce” a laser projector that is Class 3B or Class 4 (e.g., above 5 mW output), to have an approved variance from the FDA. Further, they cannot purchase the laser projector before the variance is approved.

The short version of “introduction into commerce” means just about any use, except for use at home with family and friends. For example, a variance is required if there is some type of commercial transaction, such as exhibiting at a trade show, or a person paying to see a concert or to have drinks at a bar where a laser projector is being used. It can also mean that an advertiser is paying to support an event with free admission, or the laser is advertising a product, service or event that costs money.

For any questionable “edge cases,” it may be advisable to obtain a variance anyway. This way, if authorities raise any questions, you have documentation that your use is permitted under federal law.
Exhibiting non-certified laser products
Sometimes a manufacturer will want to publicly present a new laser product which is not yet in compliance with the U.S. Federal Laser Product Performance Standard (21 CFR 1010.2). Or the manufacturer has not yet had time to certify to FDA (using Form 3632) that the laser product is compliant.

A manufacturer may publicly present a non-certified laser product, such as exhibiting at a trade show, if the product has a clearly visible label stating “This laser product sample is not yet certified to U.S. FDA safety standards and cannot be activated.” Of course, the laser product cannot be turned on or otherwise activated.

This permission to exhibit only applies to a manufacturer. A dealer, distributor, end user or other non-manufacturer can NOT present a non-certified laser product.

Note: In addition to the above labeling requirement, the LDI trade show also requires that non-certified laser products must be disabled so they cannot be activated at LDI. For example, a key could be removed from a keyswitch, or the power cord could be removed and stored.

Importation of non-certified laser products

If you wish to import a non-certified laser product, there are a number of additional steps to take. On FDA Form 2877, “Declaration for Imported Electronic Products Subject to Radiation Control Standards” which is used to import all laser products, you would check Declaration C (“The products Do Not Comply With Performance Standards”) and C2 (“Trade Show/Demonstration”).

The laser product will need to come into the U.S. under a temporary import bond, there must be a “Radiation Protection Plan”, and then after the trade show/demonstration the product must be destroyed or exported under U.S. Customs supervision.

This process is so cumbersome that it is easier to certify the laser product to FDA using FDA Form 3632, the laser product report, and wait to receive an Accession Number from FDA (as described below). Then you can begin the process of importing into the U.S. On FDA Form 2877 you would check Declaration B (“The products Comply With the Performance Standards”) and list the Accession Number of your laser product report.
Certifying a laser product
Manufacturers of laser products built in the U.S. or imported to the U.S. must certify their products to be in compliance with U.S. Federal Laser Product Performance Standard (21 CFR 1010.2). This process of self-certification requires several steps and usually a few months to complete.

Certification of laser products is required only in the United States. Therefore, laser products which are legal in other countries are not automatically legal in the US.

Several areas of work are required to certify a laser product, these include: engineering of specific safety features, safety labeling, user information, quality assurance and testing. Information on certification is in FDA Publication 86-8260, “Compliance Guide for Laser Products.”

The manufacturer can “self-certify”; they do NOT need to use a third party such as Underwriters Laboratories.

Once certification is completed, the certification shall be reported to FDA using FDA Form 3632, “Guide for Preparing Product Reports on Lasers and Products Containing Lasers,” commonly called the “laser product report.”

After the CDRH has received the laser product report, it will be given an Accession Number, which is an FDA tracking number indicating receipt of the report.

For imported products, an Accession Number is required for Customs clearance during importation of certified laser products into the U.S. (except for products imported under FDA Form 2877’s Declaration C2).

Certification of laser products also requires follow-up annual reports using FDA Form 3636. These are required to keep certification current.
Obtaining a variance
Under FDA regulations, normally any laser above Class 3R (IIIa) would not be allowed to do a laser light show. But you can apply for a “variance”, or permission to vary from FDA regulations.

The text below is taken from FDA Laser Notice 51, “Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors”. Material in brackets and italics [like this] are clarifications and comments by ILDA.

Note that the title of LN51 only seems to include the “manufacturers, dealers and distributors” of laser light show projectors. However, LN51 also applies to anyone purchasing a laser, or a laser projector, who is using it to create a laser light show. In other words, if you buy a laser projector and set it up in a public (“introduction into commerce”) show, you have become a laser light show manufacturer, and you are subject to the provisions of LN51.
Selected text from FDA Laser Notice 51

Issue

…We also know that some manufacturers of laser light show projectors sell equipment to customers without obtaining an approved variance from us, which is not acceptable.

Background

We may grant a variance from the requirements of the Federal Laser Performance Standard for Lasers and for demonstration laser products [including laser light shows]…. The variance, therefore, allows you as the manufacturer of laser light show and projector to deviate from the existing performance standards required by federal regulation.

As you know, all manufacturers of Class IIIb and IV laser light shows and laser light show projectors must have approved variances from us to perform laser light shows and introduce laser light show projectors into U.S. commerce. Prior to performing laser light shows or introducing laser light show projectors into U.S. commerce, the manufacturer must submit the following to us at CDRH:


Only the Laser Light Show Report and variance application must be submitted if an individual or firm purchases a certified laser projector for which a Product Report has already been submitted by the projector manufacturer. [If you are buying a pre-made laser projector, you will put the name and model of the laser projector on the variance application. FDA will check to see if there is an existing Product Report for this particular model of laser projector.]
A ‘variance’ is a formal permit issued by the U.S. FDA to allow a specific manufacturer or show producer to ‘vary’ from the U.S. federal regulations.

  • A variance is required for the manufacture of Class 3B or Class 4 laser projectors (aka, ‘manufacturer’s variance’). A variance is also required for the performance of a laser light show and/or laser effects, or sales/marketing demonstrations with a Class 3B or Class 4 laser projector or other laser effects device (aka, a ‘show producers variance’). A single variance can be granted for just manufacturing, or just show production, or for both.

  • No variance is required for Class 1, 2, or 3R (IIIa) laser light show products, or for laser shows and effects created with these classes of lasers.

The first step in getting a variance is to submit a variance application and the appropriate supporting documentation. Typically, at minimum, a laser product report and a sample show report must be submitted with the variance application when both a manufacturer’s variance and producer’s variance are required. Variances are not transferable. Begin the application process early, because the second step – FDA review and (hopefully) approval of new variance applications – can require several months. There is no government fee for the variance application or for the variance once approved.

The variance requirement only applies to ‘demonstration laser products’. (*see legal definition below) This means Class 3B and Class 4 laser products laser display systems, laser light show projectors, video laser projection, laser effects systems. Other types of laser products (e.g., non-demonstration products), do not require a variance for manufacture or use. This may include industrial laser cutting or marking systems creating signage, gobos, etc. This would also include general purpose laser light sources (e.g., just a bare laser itself) being marketed to manufacturers.

However, all laser products, no matter what the Class or purpose, must still be certified and operated safely, if they are to be powered on. General purpose laser sources which are Class 3B or 4 must be operated per the terms of ANSI Z136.1, and cannot be configured into any kind of effect or projector.
Importation of laser equipment for exhibition
FDA and U.S. Customs control all laser products entering the United States. Laser products shipped to the U.S. without the proper laser paperwork will generally be seized by Customs.

Carefully check all the details of your particular situation. There are several problems that can prevent the timely arrival and release of lasers when shipped to the United States. Customs regularly inspects laser shipments for the presence of required safety labeling, including the certification label.

For any Class of laser being imported from outside the U.S., the importer must fill out FDA Form 2877, “Declaration for Imported Electronic Products Subject to Radiation Control Standards” and provide it to the customs broker or shipper at the time of U.S. importation. Also, place three copies on the outside of the shipment. This form provides data to FDA about the importation and compliance status of the laser product.

The second page of Form 2877 contains instructions regarding its use.

Form 2877 indicates to FDA and Customs the safety and legal status of the laser product.

  • If the product has been certified and an Accession Number has been received from FDA, the FDA Accession Number is entered on this form allowing passage of the product into the U.S.

  • If the product report has been filed more than one year earlier, the Accession Number provided back by FDA from the submission of the annual report is typically required by the FDA (on the 2877 form) to allow a certified laser product to enter the U.S.

  • If the product has NOT been certified, it typically will enter under a temporary import bond (TIB) or similar, which ensures the product will be promptly re-exported; see Declaration C2. Products imported on a TIB cannot be powered on.

All lasers must be declared as being a ‘laser’ upon importation on the shipping paperwork. Failure to declare lasers can lead to seizure and destruction of the equipment, fines or imprisonment (although a more common result is the manufacturer or distributor is simply banned from doing work or making future sales in the U.S.).

Start all certification and variance processes early. For products which do not require a variance there can be a delay of up to 3-4 weeks to obtain an Accession Number after submission of a product report to FDA. For products requiring a variance, the delay can take many months.

Links to FDA forms

FDA general website
FDA Variance Application Process webpage — an overview of how to submit to FDA

Listing of all FDA forms

These are currently valid links. FDA sometimes changes webpages, so if a link below is broken, search for the form number or look in the Listing of all FDA forms above.

Certification: FDA Publication 86-8260, “Compliance Guide for Laser Products”
Reporting certification to FDA: FDA Form 3632, “Guide for Preparing Product Reports on Lasers and Products Containing Lasers”
General information: FDA Form 3640, “Reporting Guide for Laser Light Shows and Displays”
Variance: FDA Form 3147, “Application for a Variance from 21 CFR 1040.11(c) for a Laser Light Show, Display or Device”. Note that this can be filled out just for a device/projector, or just for a laser show/display (e.g., how the device/projector is used), or both.
Importing laser products: FDA Form 2877, “Declaration for Imported Electronic Products Subject to Radiation Control Standards”
Annual report: To keep your reports up to date, you must submit each year FDA Form 3636, “Guide for Preparing Annual Reports on Radiation Safety Testing of Laser and Light Show Products”

Companies that can assist with certification, variances and importation

Listed alphabetically:

Laser Compliance: 8820 W. Mariposa Grande, Peoria, Arizona, USA; Phone: (+1) 623-455-8565, Fax: 520-221-2929 E-Mail: sales@lasercompliance.com Website: www.lasercompliance.com, Contact: Casey Stack

Laser Safety Services: 27012 47th Pl. S., E-206, Kent, WA 98032, USA; Phone: (+1) 425-753-5644, Fax: (+1) 866-436-1531, Email: roberta@lasersafetyservices.com Website: www.lasersafetyservices.com, Contact: Roberta McHatton

Lighting Systems Design, Inc.: 4625 Winter Garden Road Suite A-2, Orlando, FL 32811-1777 USA; Phone: (+1) 407-299-9504, Fax: (+1) 407-299-3965; E-Mail: lsdi@lsdi.com, Website: www.lsdi.com Contact: Greg Makhov

Phoenix Laser Safety, LLC: 333 N. Pennington Dr. Unit 67, Chandler, Arizona 85223 USA; Phone: (+1) 480-813-1904, Fax: (+1) 480-664-8644, E-Mail: info@lasersafetyconsultant.com, Website: www.lasersafetyconsultant.com Contact: Jay Parkinson

Rockwell Laser Industries: P.O. Box 43010, 7754 Camargo Rd, Cincinnati, OH 45243 USA; Phone: (+1) 513-271-1598; Fax: (+1) 513-271-1568; E-Mail: billertle@rli.com, Website: www.rli.com Contact: Bill Ertle

For additional information

The ANSI Standard Z136.1 for Safe Use of Lasers can be obtained from the following:

  • Laser Institute of America, Suite 128, 13501 Ingenuity Drive, Orlando FL 32826, Phone: (+1) 407-380-1553; Fax: (+1) 407-380-5588; Website: www.lia.org
  • American National Standards Institute, 25 West 43rd Street, (between 5th and 6th Avenues), 4 floor, New York, NY 10036, Tel: (+1) 212-642-4900; Fax: (+1) 212-398-0023; Website: www.ansi.org

Government Safety Agencies

U.S. FDA Center for Devices and Radiological Health, Office of Compliance, HFZ-342, 2098 Gaither Road, Rockville MD 20850 USA, (+1) 301-594-4654; Fax: (+1) 301-594-4672;

For LDI, which takes place in Las Vegas, Nevada: State of Nevada Radiation Authority, Radiological Health Section Health Division, 1179 Fairview Dr., Room 102, Carson City, NV 89701 USA; Phone; (+1) 702-687-5394; Fax: (+1) 702-687-5751; E-mail: smarshall@govmail.state.nv.us; Contact: Stan Marshall, Radiation Control Specialist

Other links

See the ILDA Links and Resources page for additional links, such as to specific FDA documents and forms, and to helpful forms and checklists.