Minimizing Risk for Childrens Toy 
Laser Products 
 
Guidance for Industry and  
Food and Drug Administration Staff  
 
Document issued on December 19, 2014 
 
The draft of this document was issued on August 7, 2013. 
 
For questions about this document, contact the Division of Radiological Health at 301-796-
5790 or Daniel Hewett at 301-796-5864 or via e-mail at daniel.hewett@fda.hhs.gov.  
 
 
U.S. Department of Health and Human Services 
Food and Drug Administration 
Center for Devices and Radiological Health 
 
Office of In Vitro Diagnostics and Radiological Health 
Division of Radiological Health 
Magnetic Resonance and Electronic Products Branch  Contains Nonbinding Recommendations 
Preface 
 
Public Comment 
 
You may submit electronic comments and suggestions at any time for Agency consideration to 
http://www.regulations.gov.  Submit written comments to the Division of Dockets 
Management, Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), 
Rockville, MD 20852.  Identify all comments with the docket number FDA-2012-D-1092.  
Comments may not be acted upon by the Agency until the document is next revised or updated. 
 
Additional Copies 
 
Additional copies are available from the Internet.  You may also send an e-mail request to 
CDRH-Guidance@fda.hhs.gov to receive a copy of the guidance.  Please use the document 
number 1810 to identify the guidance you are requesting.  Contains Nonbinding Recommendations 
 
 
Minimizing Risk for Childrens Toy 
Laser Products  
 
 
Guidance for Industry and  
Food and Drug Administration Staff  
 
This guidance represents the Food and Drug Administration's (FDA's) current thinking 
on this topic.  It does not create or confer any rights for or on any person and does not 
operate to bind FDA or the public.  You can use an alternative approach if the approach 
satisfies the requirements of the applicable statutes and regulations.  If you want to discuss 
an alternative approach, contact the FDA staff responsible for implementing this 
guidance.  If you cannot identify the appropriate FDA staff, call the appropriate number 
listed on the title page of this guidance.  
 
 
Introduction 
 
This guidance is intended to inform manufacturers of laser products, FDA staff and the public 
of the Center for Devices and Radiological Healths (CDRH) current thinking on the safety of 
childrens toy laser products.  Lasers with outputs above certain levels that are operated in an 
unsafe and uncontrolled manner may cause injury to the user and/or others within range of 
the laser beam.  This is a particular concern for lasers intended for entertainment purposes, 
especially when intended to be used as toys by children. 
 
Federal law requires that, other than for certain exceptions, laser products manufactured or 
assembled after August 1, 1976 must be in compliance with the Federal Performance 
Standards for Laser Products (21 Code of Federal Regulations (CFR) 1040.10 and 1040.11).  
At present FDA regulations do not specifically identify what constitutes childrens toy laser 
products.  In June 2013, FDA issued a proposed rule that proposed to define childrens toy 
laser products and require them to be within the International Electrotechnical Commission 
(IEC) Class 1 emission limit.1  While this rulemaking process is ongoing, CDRH 
recommends that manufacturers keep childrens toy laser products within the FDA Class I or 
IEC Class 1 emission limits in order to minimize the risk they pose to users and/or others in 
range of the laser beam, including the vulnerable population for whom they are intended.2  
                                                           
1 See proposed 21 CFR 1040.10(b)(1), (2) and 1040.11(d) at 78 FR 37723 (June 24, 2013).   
2 For those childrens toy laser products that meet the definition of a demonstration laser product 
or surveying, leveling, or alignment laser product, CDRH will not object to compliance with the 
  1  Contains Nonbinding Recommendations 
 
 
This guidance, in question and answer format, is derived from questions CDRH has received 
from persons in industry, the public, and other stakeholders. 
 
FDA's guidance documents, including this guidance, do not establish legally enforceable 
responsibilities.  Instead, guidances describe the Agency's current thinking on a topic and 
should be viewed only as recommendations, unless specific regulatory or statutory 
requirements are cited.  The use of the word should in Agency guidances means that 
something is suggested or recommended, but not required. 
 
Childrens Toy Laser Products 
 
1.  Question: Why is CDRH concerned about the use of laser products? 
 
Answer: FDA has statutory authority to regulate radiation-emitting electronic products 
pursuant to sections 531 through 542 of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act) (21 U.S.C.  360hh - 360ss).  Federal law requires that, other than for certain 
exceptions, laser products manufactured or assembled after August 1, 1976 must be in 
compliance with the Federal Performance Standards for Laser Products (21 CFR 1040.10 and 
1040.11).  Lasers products may be used in unsafe or uncontrolled ways and can cause injury 
to the user and/or others in range of the laser beam.  Accordingly, FDA requires that 
manufacturers of these products incorporate safety features, warnings, and instructions for 
safe use(see 21 CFR 1040.10 and 1040.11). 
 
2.  Question: What types of lasers fall within the scope of this guidance document? 
 
Answer:  Any toy that constitutes, incorporates or is intended to incorporate a laser or laser 
system is a laser product.  See 21 CFR 1040.10(b)(21).  As stated above, laser products are 
subject to the Federal Performance Standards for Laser Products contained in 21 CFR 
1040.10 and 1040.11.  For purposes of this guidance, childrens toy laser product means a 
product primarily used as a toy that is manufactured, designed, intended or promoted for 
novelty or visual entertainment use by children under 14 years of age. 
 
This definition is intended to exclude laser products that are used in professional or academic 
settings that may be used by children (for example, laser printers, CD players, educational 
and science kits).  This guidance provides CDRHs current thinking on what constitutes 
                                                                                                                                                                                    
International Electrotechnical Commission Class 1 emission limit (set forth in IEC 60825-1:2007). 
To that end, this guidance supersedes in part the policy set forth in the Guidance on Laser Products  
Conformance with IEC 60825-1 and IEC 60601-2-22 (Laser Notice No. 50) (June 2007), available at 
http://www.fda.gov/downloads/MedicalDevices/.../ucm094366.pdf, which will cease to be effective 
by its own terms upon the effective date of amendments to the regulations applicable to laser 
products.  However, because IEC Classes 1M and 2M do not have comparable analogs in FDAs 
classification system, manufacturers should not conform to the parameters for IEC Classes 1M or 2M 
unless they also comply with FDAs performance standards for laser products. 
  2  Contains Nonbinding Recommendations 
 
 
childrens toy laser products, as well as specific safety recommendations for their 
manufacture and labeling. 
 
When assessing whether a laser product is a childrens toy laser product within the scope of 
this document, CDRH considers the following information: 
 
  Promotion, advertising, labeling, packaging, and product graphics  For example, 
advertisements, especially in childrens publications or other media, showing a 
child playing with the product or otherwise suggesting the product is intended for 
a childrens novelty or childs visual entertainment use, would generally indicate 
it is a childrens toy laser product.  Pictures on packages or labels showing play 
with the product, especially when cartoon characters make the product attractive 
to children, would also generally indicate it is a childrens toy laser product. 
  Location of product sales  For example, sales in toy stores or other settings 
specifically geared towards childrens entertainment, would generally indicate it is 
a childrens toy laser product. 
  Purpose of the product  Features or the nature of the product itself may indicate it 
is intended for use by children. 
 
CDRH may use this and other information to identify a childrens toy laser product, and 
engage manufacturers in discussions or investigations related to product safety. 
 
The following are examples of childrens toy laser products: 
 
  Lasers mounted on toy guns that can be used for aiming; 
  Spinning tops that project laser beams while they spin; 
  Hand-held lasers used during play as light sabers; 
  Dancing laser beams projected from a stationary column with bright colors or 
pictures on the box that might appeal to children; and 
  Lasers intended for entertainment that create optical effects in an open room with 
bright colors or pictures on the box that might appeal to children. 
 
3.  Question: Why is CDRH concerned in particular about childrens toy laser 
products? 
 
Answer: CDRH believes that toys containing lasers and lasers marketed as toys are 
particularly susceptible to being used in an unsafe or uncontrolled manner.  All childrens toy 
laser products should minimize risk (refer to Q&A #4).  Due to the nature of childrens toy 
laser products, the dangers of these products may not be evident to children or the adults 
supervising them.  Retinal injuries caused by laser light may go unnoticed and unreported in 
part because the retinal injuries may not be evident.  Lasers can also cause skin burns. 
 
 
 
  3  Contains Nonbinding Recommendations 
 
 
4.  Question: What is meant by minimize risk as used in this guidance? 
 
Answer:  A children's toy laser product in which the levels of laser radiation or light output 
exceed the emission levels for Class I as defined in the Federal Performance Standard for 
Laser Products ("FDA Class I") (21 CFR 1040.10 and 1040.11) or for Class 1 as defined by 
the International Electrotechnical Commission (IEC) ("IEC Class 1") under conditions of 
operation, maintenance, service, failure, or breakage do not "minimize risk" to users.  
Because childrens toy laser products are not specifically identified in the Federal 
Performance Standard, manufacturers may not think they have to comply with the current 
standard, and consequently certain childrens toys may contain lasers with power limits that 
pose a significant risk to eyesight.  As discussed above, FDA published a proposed rule that 
includes a new section to specifically identify what constitutes childrens toy laser products.  
See 78 FR 37723, 37741 (June 24, 2013).  This new section, as proposed, includes the 
definition of a childrens toy laser product and requires that the emissions of childrens toy 
laser products not exceed the IEC Class 1 limit. 
 
5.  Question: Why does CDRH believe the emission limit of IEC Class 1 sufficiently 
limits risk for childrens toy laeser products? 
 
Answer: CDRH recognizes that IEC Class 1 has a higher power limit than FDA Class I.  
CDRH has determined that lasers with emissions under either the FDA Class I or IEC Class 1 
limit sufficiently minimize risk, even when these products are used by children.  As stated in 
IEC 60825-1:2007, Annex C.2, IEC Class 1 lasers are Laser products that are safe during 
use, including long-term direct intrabeam viewing, even when exposure occurs while using 
optical viewing instruments (eye loupes or binoculars).  Output levels in excess of the IEC 
Class 1 limit are not necessary for the intended functions of toys  toys with lasers under this 
limit produce the intended visible laser light while still sufficiently minimizing risk. 
 
6.  Question: Does CDRH recommend a Class 1 label for childrens toy laser product 
within IEC Class 1 limits? 
 
Answer: Yes.  IEC Class 1 designation labeling is recommended because CDRH believes the 
presence of this designation in the labeling would clearly advise purchasers that the products 
sufficiently minimize risk (refer to Q&A #4) and have been certified as such by the 
manufacturer.  Such designation would indicate that the product is not in a higher emission 
level laser class, and that the safety controls and warnings required for higher class lasers are 
unnecessary for the product. 
 
7.  Question: For toys that contain parts that emit laser light, does the entire toy need to 
be certified? 
 
Answer: The entire toy needs to be certified as a laser product, unless the part or parts of the 
toy that can emit laser light are removable and can emit laser light independently when 
separated from the other parts of the toy, in which case only those laser-emitting part or parts 
would need to be certified.  For example, a laser gunsight that is detachable from a toy gun is 
  4  Contains Nonbinding Recommendations 
 
 
itself subject to applicable laser safety regulations and must be certified because it is a 
removable laser system (see 21 CFR 1040.10(c)(2)).  The  requirement for a certification is 
based on the removable lasers class, which is based on the accessible emission of laser 
radiation when the laser is removed.  21 CFR 1040.10(c)(2). 
 
8.  Question: Toys are regulated by the Consumer Product Safety Commission (CPSC).  
Why is CDRH providing this guidance when the CPSC already regulates toys? 
 
Answer: Toys may be subject to laws administered by the CPSC, such as the Consumer 
Product Safety Act (15 U.S.C.  2051 - 2089), as amended by the Consumer Product Safety 
Improvements Act of 2008 (Pub. L. 110314, 122 Stat. 3016 (2008)), and the Federal 
Hazardous Substances Act (15 U.S.C. 1261 - 1278a).  FDA has statutory authority to 
regulate radiation-emitting electronic products, such as laser products, pursuant to sections 
531 through 542 of the FD&C Act (21 U.S.C.  360hh - 360ss).  In the case of childrens 
toy laser products, CPSC and FDA authorities complement one another to minimize the risk 
from using these products and facilitate compliance by manufacturers. 
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