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”:
  
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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.
     

Links to FDA forms

FDA general website

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;

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. The pages that are listed will have additional links, such as to specific FDA documents and forms.