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.

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;

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.