Laser Device Regulations in the United States: An Overview

Laser devices imported or manufactured in the United States are subject to safety standards, labeling, certification, and testing requirements. This guide serves as a basic instruction to a wide range of laser devices – including barcode scanners, cosmetic laser devices, laser welding machines, and more.

Mentioned Products

• Barcode scanners
• Presentation projectors
• Aiming lasers
• Range finders
• Laser printers

CFR 21 Part 1040 – Performance Standards for Light-Emitting Products – FDA

The FDA’s CDRH (Center for Devices and Radiological Health) regulates radiation-emitting electronic products and medical devices placed in the United States. These rules are elaborated under CFR 21 Part 1040, which establishes the performance requirements for light-emitting products, including laser products and x-ray systems.

The FDA provides examples of consumer electronic products, machinery, and medical devices that include laser devices and are thus subjected to CFR 21 Part 1040 requirements:

• Optical disk players and recorders
• Bar code readers
• Printers
• Copiers
• Laser pointers and pens
• Fiber-optic systems for telephone, video, and computer networks
• Laser cutting, welding, engraving, or marking systems
• Laser light shows displays

Laser Hazard Classes

The FDA classifies laser products into several categories, according to the hazard evaluation. The higher the class, the greater harm it could cause to the users under the circumstances of incorrect use.

For products of Classes II-IV, the FDA requires a warning statement and a symbol indicating the product class and the output power affixed on the product. Below is a brief introduction to the different laser classes, with examples.

Class I

Class I laser products usually have an output power (continuous waves) of 0.4 µW and are considered safe on most occasions. Potential hazards could happen when viewed with optical aids such as magnifiers, or binoculars.

Here we list some examples of Class I laser devices:

• Laser printers
• Game consoles with DVD reader

Class II, IIa

The output power of Class II and IIa devices may reach 1 mW, with a range of 400-700nm. Hazards could increase when viewed with bare-eye or optical aids for a long period of time.

Here we list some examples of Class II and IIa laser devices:

• Barcode scanners
• Presentation projectors
• Aiming lasers
• Range finders

The FDA requires that Class II and Class IIa laser products should bear the following warning statement in uppercase letters on the product label:

“LASER RADIATION–DO NOT STARE INTO BEAM”

“CLASS II LASER PRODUCT”

Class IIIa

The power of Class IIIa laser products is stronger than Class II and IIa, usually in the output range of 1-5 mW. Some laser products of this class can cause instant hazards to human health, such as temporary blindness or burnt injuries. When viewing the laser beams with focusing function optical aids, the hazard degree increases.

Here we list some examples of Class IIIa laser devices:

• Laser pointers
• Laser welders
• Laser marking machines

The following warning statement should be written in uppercase letters displayed on the Class IIIa product label:

“LASER RADIATION–AVOID DIRECT EYE EXPOSURE”

“CLASS IIIa LASER PRODUCT”

Class IIIb

Laser products of Class IIIb might cause immediate skin and eye hazards to the users from the direct beam. The output of Class IIIb ranges between 5-500 mW.

Here we list some examples of Class IIIb laser devices:

• Stage show laser projectors
• Industrial lasers
• Laboratory lasers
• Stereolithography laser machines

Warning statement for Class IIIb should be written in uppercase letters containing the following information:

“LASER RADIATION–AVOID DIRECT EXPOSURE TO BEAM”

“CLASS IIIb LASER PRODUCT”

Class IV

Laser products of Class IV have a high output power and might cause immediate serious permanent skin hazards and eye hazards to the users under the direct or reflected beam. In some cases, they might even lead to fire hazards.

Here we list some examples of Class IIIb laser devices:

• Industrial laser cutting machines
• Military laser guns
• Research lasers
• Eye surgery laser machines
• Laser skin treatment machines

Each Class IV laser product should have an affixed label bearing the following warning statement:

“LASER RADIATION–AVOID AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION”

“CLASS IV LASER PRODUCT”

Standards and Testing Requirements

The FDA’s CDRH requires laser products placed on the US market to comply with the technical and labeling requirements specified in CFR 21 Part 1040.10 and Part 1040.11.

The CDRH recognizes the following two standards published by the IEC (International Electrotechnical Commission):

• IEC 60825-1 – Safety of Laser Products
• IEC 60601-2-22 – Medical Electrical Equipment

We describe these standards in more detail below in this guide. You can visit the CDRH’s Laser Notice No.50 to read the detailed guidance.

FDA Form 2877 – Documentation

The FDA requires that importers and manufacturers of radiation-emitting electronic products, including laser products, submit Form 2877 – Declaration for Imported Electronic Products Subject to Radiation Control Standards.

Importers and manufacturers need to provide information such as:

• Name and address of manufacturing site
• Country of origin
• Product description
• Model number

You can download Form 2877 from the FDA’s website.

Labeling Requirements

According to CFR 21 Part 1010.2, importers and manufacturers of laser products should affix a label or a tag to the product. The label should declare compliance of the products to applicable standards and legal requirements in the US. All the information should be written in legible English language.

Here some examples of the label, which is considered to be the certificate of the product:

“Complies with 21 CFR Chapter 1, Subchapter J.”

“Complies with 21 CFR Part 1040.10 and 1040.11.”

Section CFR 21 Part 1040.10 also explains the general labeling requirements for laser products. When applicable, depending on the hazard class. the following content should be displayed on the product:

• A warning logotype
• A specific warning statement
• Maximum output
• Pulse duration (if pulsed)
• Laser medium or emitted wavelength(s)
• An identification label

The identification label must contain the following information:

• Name and address of the manufacturer
• Place of manufacture
• Month and year of manufacture (written in integrity)

Test Report

Lab testing, for instance against relevant IEC or other standards, is the only to make sure that your product complies with the CDRH’s laser device requirements. To confirm the compliance of the laser device, importers or manufacturers should test their laser device at a reliable testing agency, such as Eurofins, UL, and TÜV SÜD.

Relevant authorities, retailers, Amazon, or consumers might require a copy of the test report, or other compliance documents, at any time.

Registration and Device Listing

The FDA’s CDRH requires to register medical devices that include a laser beam and provide the following information:

• Product name
• Model number
• Laser medium or emitted wavelength(s)
• Name and address of the importer or manufacturer

The registration procedures and instructions are described in Part 807 – Establishment Registration and Device Listing for Manufacturers and Initial Importers of Devices.

Importers of laser products are required to submit the following registration information:

• Name and mailing address of the device establishment
• Web site address of the device establishment
• Company name
• Trade name
• Company address
• The contact number of the responsible party
• Email address

Quality System and GMP Requirements

The FDA provides quality system establishment guidance for manufacturers in Part 820 – Quality System Regulation. The Quality System Regulation sets up the general principles and rules for all finished devices intended for human use concerning the following aspects:

• Product design
• Manufacture
• Packaging
• Labeling
• Storage
• Installation
• Services

The Quality System Regulation applies to medical devices, including devices that feature laser beams.

Here we list some example of medical laser devices:

• Tattoo removers
• Scar removers
• Vision correction equipment
• Tooth whitening devices
• Tumor removal devices

FCC Part 15

FCC Part 15 regulates electronic and electrical devices that operate in the radio frequency range of 9 kHz to 3,000 GHz and are able to emit radiofrequency energy intentionally or unintentionally, which might cause electromagnetic interference to devices that affect authorized radio communication services.

Lasers can emit radiofrequency beams and thus products that are incorporated with laser devices might be under the regulated scope of the FCC rules on electronic devices, codified in Part 15 of the CFR Title 47.

Product Scope

• Laser pointers
• DVD players
• Wireless printers

Technical Requirements

To comply with the FCC standards for electronic devices, manufacturers or importers should refer to the technical requirements elaborated in Part 15 of CFR Title 47, which includes general technical requirements such as operation limits, RF emission limits, and antenna power limits.

Importers or manufacturers should determine under which classification their products are (i.e. Class A or Class B).

SDoC

The FCC requires that importers and manufacturers of regulated electronic devices must draft a copy of Supplier’s Declaration of Conformity (SDoC), which is a document that includes eligible test reports and other information demonstrating the product’s compliance to applicable standards.

Note that the SDoC’s responsible party must be located in the United States. For foreign importers or manufacturers not located in the country, a telecommunication certification body (TCB) or other US representatives must be appointed following the proper procedures.

Labeling

The FCC requires that regulated devices must bear an identification label on the product itself. In cases that the size of the product is limited, the following information should be displayed on the product packaging:

• Name of the manufacturer or importer
• Postal address of the responsible party
• The contact number of the responsible party
• Product model or serial number
• Statement of compliance
• FCC ID (for intentional radiators)

Test Report

To comply with FCC’s requirements, importers or manufacturers of laser devices should consult a testing agency to know better what technical requirements apply to their products, and perform the relevant tests.

For example, the laser device may need to comply with FCC’s requirements such as:

• Operation band
• Measurement standards

Test reports must be attached to the SDoC. Also, consumers, marketplaces, retailers, distributors, or the authorities might require a copy of the reports at any time.

OSH Act

The US Occupational Health and Safety Administration (OHSA) develops safety standards and regulations to protect the safety of workers in the workplace.

For example, the following standards mention laser products:

1. 29 CFR 1926.54 – General safety operation rules for the construction industry

2. 29 CFR 1926.102(b)(2) – Safety requirements during the welding operation and protection methods for eye and face safety

More in general, the OSH Act requires that laser products that are used in the workplace must conform to applicable regulations and standards developed by other federal agencies, such as the FDA and the FCC.

The OSH Act also mentions a standard issued by ANSI (American National Standard Institute), which is ANSI Z136.1 – Safe Use of Lasers. It comments that even though the ANSI standards are voluntary, they can be adopted or cited depending on the practical applications.

ANSI Standards

The ANSI has developed several standards for laser devices, both for commercial and industrial use.

ANSI Z136.1 – Safe Use of Lasers

ANSI Z136.1 applies to general consumer-used laser products and systems that operate at wavelengths between 180nm and 1000um.

This standard concerns the safety use of laser products by classifying laser products according to the output power and hazard levels produced by the products, specifying appropriate controls and operating methods for each classification, providing education and training instructions, and medical examinations when laser-related injuries happen.

However, technical information on measurements, calculations, and biological effects is also provided within the standard and its appendixes.

Other Relevant ANSI Standards

Other ANSI standards for the safety of laser products also include:

a. ANSI Z136.2 Safe Use of Optical Fiber Communication Systems Utilizing Laser Diode and LED Sources

b. ANSI Z136.3 Safe Use of Lasers in Health Care

c. ANSI Z136.5 Safe Use of Lasers in Educational Institutions

d. ANSI Z136.6 Safe Use of Lasers Outdoors

e. ANSI Z136.7 American National Standard for Testing and Labeling of Laser Protective Equipment

f. ANSI Z136.9 American National Standard for Safe Use of Lasers in Manufacturing Environments

IEC Standards

In this section, we introduce two IEC standards that concern the safety use and technical requirements of consumer laser products.

IEC 60825-1 – Safety of Laser Products

IEC 60825-1 applies to laser products emitting laser radiation in the wavelength range 180 nm to 1 mm.

It explains the rules to determine product scope, classification principles, labeling and marking requirements, and other safety requirements for laser products.

IEC 60825 is recognized by the FDA for laser products imported to the United States on the condition that the products also comply with the relevant CFR sections on laser products:

• 21 CFR Section 1040.10 and Section 1040.11
• 21 CFR Section 1010.2 and Section 1010.3
• 21 CFR Section 1002.10

IEC 60601-2-22 – Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment

IEC 60601-2-22 lays down safety and performance requirements for diagnostic and therapeutic laser equipment classified as Class 3B or Class 4 in IEC 60825-1. IEC 60601-2-22 applies to laser products intended for surgical, therapeutic, cosmetic, or veterinary purposes.

NFPA 115: Standard for Laser Fire Protection

The NFPA (National Fire Protection Association) is a non profit organization that develops standards for flammable products or products that have the potential to cause fire hazards, for the purpose of decreasing accidents and injuries caused by non-compliant products.

NFPA 115 is a standard that provides minimum fire protection requirements in regard to the design, manufacture, installation, and use of laser products. This standard also involves the classification of lasers and the safe operation of the laser devices.

Country of Origin

Country of Origin labeling is mandatory for imported products to the United States. Importers and manufacturers should have this label attached or engraved on the product itself. This rule is also applicable to laser products.

State Regulations

Several states in the US have developed their own regulations for laser devices including Florida, Georgia, Illinois, Massachusetts, New York, Texas, and Washington.

New York

The New York State Code Rule 50 Regulation lays down mechanical, operational, and regulatory requirements for laser devices and systems sold in New York.

Massachusetts

The Massachusetts Radiation Control Program rules are contained in 105 Code of Massachusetts Regulations 121.000, Regulations for the Control of Lasers.

This regulation requires that all laser products marketed in the state of Massachusetts must comply with ANSI Z136. ANSI Class 3B or 4 lasers must go through the registration processes before selling in the market.

RoHS

The Restriction of Hazardous Substances (RoHS) Directive is originally an EU directive regulating the chemical safety of electronic products. Later, several states in the US, such as California, Illinois, and New York, have developed similar RoHS regulations, aiming to limit the amount of heavy metals and phthalates contained by the parts and components of the electronic products, including laser electronics, such as:

• Lead
• Mercury
• Cadmium
• Hexavalent chromium
• PBB
• PBDE
• DEHP
• BBP
• DBP
• DIBP

These substance are limited to 0.1% by weight.

California Prop 65

Importers and manufacturers that intend to sell in California should also ensure that consumers’ laser devices comply with the heavy metal and other chemical requirements set by California Proposition 65.

The following substances are restricted by California Proposition 65:

• Antimony
• Arsenic
• Beryllium
• Cadmium
• Chromium
• Lead
• Mercury
• Nickel
• Selenium
• DIDP
• DINP
• DBP
• DNHP

Lab Testing

Third-party lab testing is necessary to verify the compliance and general safety of laser devices sold in the United States.

Here is a list of some reputable lab testing companies that offer laser devices lab testing:

• TÜV SÜD
• UL
• Eurofins
• Modulight
• Lasermet