Contains Nonbinding Recommendations
Laser Products  Conformance with 
IEC 60825-1 Ed. 3 and 
IEC 60601-2-22 Ed. 3.1 
(Laser Notice No. 56)
Guidance for Industry and
Food and Drug Administration Staff
Document issued on February 21, 2023. 
Document originally issued on May 8, 2019.
For questions about this document, contact Office of Health Technology 8 (OHT8): Office 
of Radiological Health at RadHealth@fda.hhs.gov.
U.S. Department of Health and Human Services
Food and Drug Administration 
Center for Devices and Radiological Health Contains Nonbinding Recommendations
Preface
Public Comment
You may submit electronic comments and suggestions at any time for Agency consideration to 
https://www.regulations.gov. Submit written comments to the Dockets Management Staff, Food 
and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD 20852. 
Identify all comments with the docket number FDA-2017-D-7011. 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 
GUI01500024 to identify the guidance you are requesting. Contains Nonbinding Recommendations
Laser Products  Conformance with 
IEC 60825-1 Ed. 3 and 
IEC 60601-2-22 Ed. 3.1 
(Laser Notice No. 56)
Guidance for Industry and
Food and Drug Administration Staff
This guidance represents the current thinking of the Food and Drug Administration 
(FDA or Agency) on this topic. It does not establish any rights for any person and is not 
binding on FDA or the public. You can use an alternative approach if it satisfies the 
requirements  of  the  applicable  statutes  and  regulations.  To  discuss  an  alternative 
approach, contact the FDA staff or Office responsible for this guidance as listed on the 
title page.
I.  Introduction
This guidance describes the Food and Drug Administrations (FDA) approach regarding 
manufacturers compliance with FDAs performance standards for laser products. FDA 
recognizes that while there are many similarities between International Electrotechnical 
Commission (IEC) standards 60825-1: Safety of laser products - Part 1: Equipment 
classification, and requirements, Edition 3.0 and 60601-2-22: Medical electrical equipment - 
Part 2-22: Particular requirements for basic safety and essential performance of surgical, 
cosmetic, therapeutic and diagnostic laser equipment, Edition. 3.1 and FDAs laser performance 
standards, there are clauses of these IEC standards that differ significantly from FDAs 
performance standards for laser products. For the manufacturers that conform to the clauses of 
IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 that FDA identifies as comparable with 21 CFR 
1040.10 and 1040.11, FDA does not intend to enforce the applicable requirements in 21 CFR 
1040.10 and 1040.11.
In general, FDAs guidance documents, including this guidance, do not establish legally 
enforceable responsibilities. Instead, guidance describes the Agencys 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.
1 Contains Nonbinding Recommendations
II.  Background
FDA regulates radiation-emitting electronic products, including all types of lasers products. Laser 
product means any manufactured product or assemblage of components which constitutes, 
incorporates, or is intended to incorporate a laser or laser system. A laser or laser system that is 
intended for use as a component of an electronic product shall itself be considered a laser product 
(see 21 CFR 1040.10(b)(21)). The Agency sets radiation safety product performance standards that 
must be met by manufacturers in order for laser products to be legally sold in the U.S. market. 
Laser products may fall under both the definition of a medical device and that of an electronic 
product, under sections 201(h) and 531(2) of the Federal Food, Drug, and Cosmetic Act (FD&C 
Act), respectively. Such products are subject to the provisions of the FD&C Act and its 
implementing regulations that apply to medical devices1 and electronic products.2,3
Among other requirements, laser products for introduction into United States commerce, including 
imports, must:
 Comply with 21 CFR 1040.10 and 1040.11 as applicable,
 Be certified and identified in accordance with 21 CFR 1010.2 and 1010.3, and
 Be reported in accordance with 21 CFR 1002.1.
Manufacturers should be aware that CDRH previously issued notices to laser product manufacturers 
and importers and those are available on FDAs website at https://www.fda.gov/radiation-emitting-
products/electronic-product-radiation-control- program/electronic-product-radiation-control-
program-industry-guidance. 
FDA recognizes that the International Electrotechnical Commission (IEC) is a global 
organization that prepares and publishes international standards for electrical, electronic, and related 
technologies, including laser products. This means that manufacturers distributing products in the 
U.S. and other countries might have to ensure conformance of their products with IEC standards, as 
well as comply with FDA regulatory requirements. Complying with FDA regulations and 
conforming to the identified IEC standards may cause manufacturers to duplicate their efforts.
FDA acknowledges the advantages of a universal set of device-specific criteria and requirements. 
Moreover, FDA believes that under the circumstances described in this guidance, conformance with 
certain IEC standards would provide adequate protection of the public health and safety for laser 
products similar to FDAs performance standards in 21CFR 1040.10 and 1040.11.
FDA eventually intends to amend its standards for laser products at 21 CFR 1040.10 and 1040.11 to 
harmonize many of its requirements with those of the IEC because FDA acknowledges the 
advantages of one set of criteria and requirements worldwide. Until these requirements are 
harmonized, for laser product manufacturers that conform with the comparable clauses in IEC 
60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, as described in this document, FDA does not intend to 
1 https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation 
2 https://www.fda.gov/radiation-emitting-products/electronic-product-radiation-control-program 
3 The regulations specific to medical devices and electronic products are found in 21 CFR Chapter I Subchapter H on 
Medical Devices and Subchapter J on Radiological Health, respectively.
3 Contains Nonbinding Recommendations
enforce the comparable requirements in 21 CFR 1040.10 and 21 CFR 1040.11.
In June 2007 FDA issued a guidance entitled Laser Products  Conformance with IEC 60825-1 
and IEC 60601-2-22 (Laser Notice No. 50); Guidance for Industry and FDA Staff.4 Laser Notice 
No. 50 states that FDA does not intend to enforce applicable requirements of 21 CFR 1040.10 if the 
manufacturers comply with comparable clauses of IEC 60825-1 Ed. 1.2 or 2 and IEC 60601-2-22 
Ed. 3, as set forth in Laser Notice No. 50. This guidance (Laser Notice No. 56) does not replace the 
recommendations in Laser Notice No. 50.
This guidance announces that if the laser product conforms to the clauses of IEC 60825-1 Ed. 3 and 
IEC 60601-2-22 Ed. 3.1 identified in Section III as comparable with 21 CFR 1040.10 and 1040.11, 
FDA does not intend to enforce applicable FDA requirements. For example, FDA does not intend 
to enforce requirements relating to obtaining variances for laser products that conform to the 
relevant portions of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 identified as comparable with 
21 CFR 1040.10 and 1040.11, as described in Section III below.
III. Policy
FDA recognizes that there are many similarities between FDAs performance standards for laser 
products (21 CFR 1040.10 and 1040.11) and comparable clauses of IEC standards (IEC 60825-1 
Ed. 3 and IEC 60601-2-22 Ed. 3.1).
In particular, FDA does not intend to enforce the requirements in the following sections of 21 CFR 
part 1040, if the laser products are in conformance with the comparable clauses of IEC 60825-1 Ed. 
3, and when applicable, 60601-2-22 Ed. 3.1 (for medical devices). Unless identified as a not 
comparable IEC clause in subsection A below, FDA considers all other clauses of IEC 60825-1, Ed. 
3 and IEC 60601-2-22 Ed. 3.1 as comparable to the following FDA performance standards:
1040.10(b) Definitions 
1040.10(c)(1) Classification*
1040.10(d) Accessible emission limits 
1040.10(e) Tests for determination of compliance 
1040.10(f)(1) Protective housing
4https://www.fda.gov/regulatory-information/search-fda-guidance-documents/laser-products-conformance-
iec-60825-1-and-iec-60601-2-22-laser-notice-no-50      
3 Contains Nonbinding Recommendations
1040.10(f)(2) Safety interlocks** 
1040.10(f)(3) Remote Interlock connector 
1040.10(f)(4) Key control
1040.10(f)(5) Laser radiation emission indicator 
1040.10(f)(6) Beam attenuator
1040.10(f)(7) Location of controls 
1040.10(f)(8) Viewing optics 
1040.10(f)(9) Scanning safeguard 
1040.10(g) Labeling requirements 
1040.10(h)(1) User information 
1040.11(a) Medical laser products
* Manufacturers should apply the interpretation sheets IEC 60825-1/ISH1:Interpration sheet 1  
Safety of laser products  Part 1: Equipment classification and requirements and IEC 60825-1/ISH2: 
Interpretation sheet 2  Safety of laser products  Part 2: Safety of optical fibre communication 
systems (OFCS). FDA may request additional information from your product Classification Testing 
to confirm that the laser product is properly classified.
** IEC 60825-1 Ed. 3 (6.3) indirectly requires redundancy or safe-failure for safety interlocks 
designed to protect against human access from Class IIIb or IV laser radiation. This indirect 
requirement is through the Classification Rules (4.3), reasonably foreseeable single-fault condition 
sub-clause. Accordingly, laser products conforming to the identified clauses of the IEC standards 
must have a redundancy or safe-failure in order to be considered comparable to 21 CFR 1040.10.
FDA eventually intends to harmonize, through rulemaking, the requirements of 21 CFR Part 1040 
with those of the IEC standards.
A.  Not Comparable IEC Clauses
Certain clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 are considered not comparable to 
FDAs performance standards under 21 CFR 1040.10 and 1040.11 for the reasons discussed below. 
While some information in these clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 are not 
comparable with, or there may not be a comparable section in 21 CFR 1040.10 and 1040.11, laser 
product manufacturers may find this information useful for inclusion in correspondence and 
applications for variance or exemption submitted to FDA under 21 CFR 1010.4 or 1010.5, 
respectively. These clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 may also be useful in 
preparation of required reports in 21 CFR 1002 or in inclusion in the informational requirements in 
21 CFR 1040.10(h), provided the information does not conflict with FDAs performance standards.
 The following IEC clauses and annexes of IEC 60825-1 Ed. 3 are not comparable to 
FDAs performance standards under 21 CFR 1040.10 and 1040.11 because they are 
either not applicable or inconsistent with FDAs performance standards: 1, 2, 3.4., 3.15, 
3.16, 3.37, 3.45, 3.47, 3.50, 3.52, 3.59, 3.64, 3.65, 4.4 , 6.13 , 6.15.1, 6.16, 8.2, 9.1, 9.3, 
9.4 , 9.5 and Annexes A through G. 
 Sub-clause 3.25 (definition of collateral radiation) of IEC 60825-1 Ed. 3 is considered 
not comparable to FDAs performance standards under 21 CFR 1040.10 because it does 
not include all electromagnetic radiation (e.g., X-ray emissions) found in the FDA 
definition at 21 CFR 1040.10(b)(12). However, it is not likely that laser products with 
electrical potentials of less than 20 kV will emit X-rays.
4 Contains Nonbinding Recommendations
 Sub-Clause 3.48 (definition of laser product) of IEC 60825-1 Ed. 3 is considered not 
comparable to FDAs performance standards under 21 CFR 1040.10 because the IECs 
definition does not include laser products intended for use as components, which are 
defined as laser products in the FDA definition at 21 CFR 1040.10(b)(21). However, 
IEC 608-25-1 Ed.3 acknowledges in Clause 1  Scope and Object that certain 
components or repair parts are laser products. FDA requires that component and repair 
(or replacement) laser products comply with FDAs performance standards for laser 
products (see 21 CFR 1040.10(a)).
 Sub-clause 3.49 (definition of laser radiation) of IEC 60825-1 Ed. 3 is considered not 
comparable to FDAs performance standards under 21 CFR 1040.10 because it does not 
include all electromagnetic radiation emitted by the laser product that is detectable with 
such controlled, stimulated radiation emitted through the aperture stop (except collateral 
radiation) as found in the FDA definition at 21 CFR 1040.10(b)(22).
 Sub-clause 5.2(f) of IEC 60825-1 Ed. 3 is considered not comparable to FDAs 
performance standards under 21 CFR 1040.10 because it instructs to avoid or eliminate 
the contribution of collateral radiation to the measurement of laser radiation and because 
it contradicts clause 4.3(b)(1). While it would not be appropriate to include collateral 
radiation in measurements of laser radiation in Clause 5.2 Measurement of laser 
radiation, manufacturers are instructed by clause 4.3(b)(1) to include collateral radiation 
in measurements when classifying laser products. FDA also requires that collateral 
radiation be measured separately when making classification measurements under 21 
CFR 1040.10(c).
 Sub-clause 6.1 (general remarks and modifications) of IEC 60825-1 Ed. 3 is considered 
not comparable to FDAs performance standards under 21 CFR 1040.10 because it does 
not require recertification and re-identification as required by 21 CFR 1040.10(i). 
Otherwise, Clause 6.1 contains information that manufacturers may find helpful, such as 
ensuring that personnel responsible for classification receive training. You may wish to 
include such information in reports/submissions to FDA.
 Sub-clause 6.2.3 (removable laser system) of IEC 60825-1 Ed. 3 is considered not 
comparable to FDAs performance standards under 21 CFR 1040.10(c)(2) because the 
FDA definition is not limited to plug-in connections to electrical mains or a battery.
 Sub-clause 6.15.2 (collateral radiation) of IEC 60825-1 Ed. 3 is considered not 
comparable to FDAs performance standards under 21 CFR 1040.10 because it limits 
collateral radiation by laser maximum permissible exposure values instead of a laser 
class accessible emission limit as in 21 CFR 1040.10(d).
The FDA performance standards for laser products requires the use of admissible 
emissions limits values, including those for x-rays. Specifically, the performance 
standard does not make assessments of collateral radiation dependent upon levels of 
concern, rather such assessments are mandatory in 21 CFR 1040.10(d).
  Clause 8 (Other informational requirements) of IEC 60825-1 Ed. 3 is considered not 
comparable to FDAs performance standards under 21 CFR 1040.10 because it does not 
include collateral radiation as in 21 CFR 1040.10(h). Otherwise, Clause 8 contains 
information that manufacturers may find helpful, such as the applicable MPE and 
NOHD for Class 3B and Class 4 laser products. You may wish to include such 
information in reports/submissions to FDA.
5 Contains Nonbinding Recommendations
For the IEC clauses listed below, FDA recommends you follow other FDA issued guidance 
documents, as appropriate:
  Sub-clause 4.4 (Laser products designed to function as conventional lamps) of IEC 
60825-1 Ed. 3: For guidance on the application of international consensus standards to 
laser illuminated projectors, please see FDAs guidance entitled Classification and 
Requirements for Laser Illuminated Projectors (LIPs) (Laser Notice No. 57); Guidance 
for Industry and Food and Drug Administration Staff.5
 Sub-clause 9.4 Electric toys of IEC 60825-1 Ed. 3: For guidance on electric toys, 
please see FDAs guidance entitled Minimizing Risk for Childrens Toy Laser 
Products; Guidance for Industry and Food and Drug Administration Staff.6
B.  Performance Standards Not Subject to this Guidance
This guidance does not affect the following sections of FDAs performance standards for laser 
products. These FDA performance standards are beyond the scope of the IEC standards, are 
sufficiently different from the IEC standards, or are not normative and included as 
recommendations in the Users Guide clause of the IEC standards. Specifically:
1010.2 Certification
1010.3 Identification
1010.4 Variances
1010.5 Exemptions for products intended for United States Government use 
1040.10(a) Applicability
1040.10(c)(2) Removable laser systems 
1040.10(h)(2) Purchasing and servicing information 
1040.10(i) Modification of a certified product
1040.11(b) Surveying, leveling and alignment laser products 
1040.11(c) Demonstration laser products
5https://www.fda.gov/regulatory-information/search-fda-guidance-documents/classification-and-requirements-laser-
illuminated-projectors-lips-laser-notice-no-57 
6https://www.fda.gov/regulatory-information/search-fda-guidance-documents/minimizing-risk-childrens-toy-laser-
products  
6 Contains Nonbinding Recommendations
C.  Certification Requirements
Manufacturers of laser products must certify that their products comply with FDAs performance 
standards (see 21 CFR 1010.2). The certification must be provided on a label or tag permanently 
affixed to or inscribed on the product so as to be legible, readily accessible to view when the 
product is fully assembled for use, and the label or tag must be in the English language (see 21 CFR 
1010.2(b)). FDA does not intend to enforce the requirements in 21 CFR 1010.2 for manufacturers 
that conform to comparable clauses of IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, and who 
use the following statement on the certification label or tag:
For laser products that are also considered a medical device:
1. Complies with FDA performance standards for laser products except for 
conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, as described in 
Laser Notice No. 56, dated May 8, 2019. or
2. Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 
60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1, as described in Laser Notice No. 56, 
dated May 8, 2019.
For laser products that are not considered a medical device:
1. Complies with FDA performance standards for laser products except for 
conformance with IEC 60825-1 Ed. 3., as described in Laser Notice No. 56, dated 
May 8, 2019. or
2. Complies with 21 CFR 1040.10 and 1040.11 except for conformance with IEC 
60825-1 Ed. 3., as described in Laser Notice No. 56, dated May 8, 2019.
Under 21 CFR 1010.2(c), this certification must be based upon a test, in accordance with the 
standard, of the individual article to which it is attached or upon a testing program that is in 
accordance with good manufacturing practice. The manufacturers quality system should address 
various aspects of radiation safety and conformity to standards through design controls. Testing 
results should be documented and placed in the firms records.
As identified in Table 1 of 21 CFR 1002.1, manufacturers of certain laser products must submit 
product reports or supplemental reports that describe changes to products made in accordance with 
this guidance. Manufacturers may use Form FDA 3632 Guide for Preparing Product Reports for 
Lasers and Products Containing Lasers7 to submit these reports.
7https://www.fda.gov/media/72593/download 
7