Please note -- by the end of 2024, the U.S. Food and Drug Administration (FDA) 
intends to withdraw Laser Products - Conformance with IEC 60825-1 and IEC 
60601-2-22 (Laser Notice No. 50). This change is because newer International 
Electrotechnical Commission (IEC) standards have been issued. This 
announcement ensures stakeholders have time to transition to Laser Products - 
Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1 (Laser Notice No. 
56).
Laser Notice No. 56 describes:
 FDAs current approach to manufacturers compliance with the FDAs 
performance standards for laser products, and
 how laser manufacturers can use portions of IEC 60825-1 Edition 3.0 and 
60601-3-22 Edition 3.1 with the FDAs performance standard when 
certifying laser products.
For additional guidance, please see Getting a Radiation Emitting Product to 
Market: Frequently Asked Questions | FDA. Contains Nonbinding Recommendations 
Guidance for Industry and FDA 
Staff 
Laser Products  Conformance 
with IEC 60825-1 and IEC 60601-
2-22; Guidance for Industry and
FDA Staff 
(Laser Notice No. 50) 
Document issued on June 24, 2007  
 This document supersedes Laser Products  Conformance with IEC 
60825-1, Am. 2 and IEC 60601-2-22; Final Guidance for Industry and FDA 
(Laser Notice No. 50), July 26, 2001.  
For questions regarding this document send an email message to RadHealth@fda.hhs.gov. 
U.S. Department of Health and Human Services 
Food and Drug 
Administration 
Center for Devices and Radiological Health 
 Electronic Products Branch 
Division of Mammography Quality and Radiation Programs 
Office of Communication, Education, and Radiation Programs 
1 Contains Nonbinding Recommendations 
Preface 
Public Comment 
Written comments and suggestions may be submitted at any time for Agency consideration to 
the Division of Dockets Management, Food and Drug Administration, 5630 Fishers Lane, 
Room 1061, (HFA-305), Rockville, MD, 20852.  When submitting comments, please refer to 
the exact title of this guidance document.  Comments may not be acted upon by the Agency 
until the document is next revised or updated.   
Additional Copies 
You may obtain additional copies by sending an e-mail request to CDRH-
Guidance@fda.hhs.gov to receive an electronic copy of the guidance. Please use the 
document number (1346) to identify the guidance you are requesting.
2 Contains Nonbinding Recommendations 
 
 
Guidance for Industry and FDA Staff  
 
Guidance on Laser Products  
Conformance with IEC 60825-1  
and IEC 60601-2-22  
(Laser Notice No. 50)  
 
 
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 describes the conditions under which laser product manufacturers may 
introduce into United States commerce laser products that comply with the IEC standards 
60825-1, as amended, and 60601-2-22. This guidance also describes additional requirements 
of the CDRH standard and alternate certification statements to be used with such products.  
Laser products for introduction into commerce in or imported into the United States 
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 1002.10.  
 
CDRH has issued notices to laser product manufacturers and importers stating non-objection 
to:  
  Lack of emission indicators or beam attenuators on Class II and Class IIIa systems, 
and  
  Hazard warning labels as specified in IEC 60825-1.  
 
CDRH will not object to conformance with many sections of IEC 60825-1, as amended, and 
  3 Contains Nonbinding Recommendations 
 
IEC 60601-2-22 as alternatives to comparable sections of 21 CFR 1040.10 and 1040.11. 
CDRH plans to amend federal regulations for laser products to reflect those sections of the 
IEC standards.  CDRH is also listing sections of its standard that contain requirements to 
which manufacturers must conform. This action is appropriate because of the Center's intent 
to harmonize its requirements with many of those of the IEC standards.  
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.  
 
 
The Least Burdensome Approach 
We believe we should consider the least burdensome approach in all areas of medical device 
and electronic product regulation.  This guidance reflects our careful review of the relevant 
scientific and legal requirements and what we believe is the least burdensome way for you to 
comply with those requirements.  However, if you believe that an alternative approach would 
be less burdensome, please contact us so we can consider your point of view.  You may send 
your written comments to the contact person listed in the preface to this guidance or to the 
CDRH Ombudsman.  Comprehensive information on CDRH's Ombudsman, including ways 
to contact him, can be found on the Internet at http://www.fda.gov/cdrh/ombudsman/.  
 
 
1.  Issue 
 
The Food and Drug Administrations (FDA) Center for Devices and Radiological Health 
(CDRH) 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 60825-1 and 60601-2-22 
standards.  Although CDRH began its amendment process in anticipation of the amendment 
of IEC 60825-1, it is not yet ready to publish an amendment.  CDRH has acknowledged the 
advantages of one set of criteria and requirements worldwide.  Edition 1.2 of IEC 60825-1 
was published in August, 2001.  Edition 2 was published in March, 2007.  Edition 2 of IEC 
60601-2-22 was published in November, 1995.  Edition 3 was published in May, 2007.  As a 
result, manufacturers distributing products in both the U.S. and countries that require 
conformance with, or that recognize IEC 60825-1, will have to evaluate the conformance of 
their products with this standard.  This requires them to often change the hazard 
classification of their products.  These manufacturers are requesting relief from CDRH so 
that they will have to comply with only one laser product radiation safety standard. 
 
 
  4 Contains Nonbinding Recommendations 
 
2.  Guidance 
 
For what sections of 21 CFR can conformance with sections of IEC 60825-1 and 60601-
2-22 be substituted? 
Effective immediately, and until the effective date(s) of any amendments of the Federal 
regulations affecting laser products, CDRH will not object to conformance with the 
comparable sections of IEC 60825-1, Editions 1.2 or 2 or 60601-2-22 in lieu of 
conformance with the following sections of 21 CFR 1040:  
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  
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  
CDRH intends to harmonize the requirements of these sections with those of the IEC 
standards.  
Which applicable sections of 21 CFR are unaffected by this guidance? 
The following sections are unaffected.  Laser products must conform to the following 
sections of the CDRH standards:  
1010.2 Certification  
1010.3 Identification  
1010.4 Variances  
1040.10(a) Applicability  
1040.10(c)(2) Removable laser systems  
1040.10(f)(10) Manual reset mechanism  
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  
CDRH intends to retain these requirements even if they differ from the IEC. They are either 
beyond the scope of the IEC standard, are sufficiently different, or are not normative and 
included as recommendations in the Users Guide section of the IEC standard.  
  5 Contains Nonbinding Recommendations 
 
What should manufacturers do in using this guidance?  
1.  Use the following modified statement of compliance on the certification label: 
Complies with FDA performance standards for laser products except for deviations 
pursuant to Laser Notice No. 50, dated (Insert date of this guidance.) or Complies 
with 21 CFR 1040.10 and 1040.11 except for deviations pursuant to Laser Notice No. 
50, dated June 24, 2007; and  
2.  Submit product reports or supplemental reports to describe changes to products in 
accordance with this guidance.  
 
The effectiveness of this guidance will end on the effective date(s) of any amendments to the 
Federal regulations applicable to laser products under Chapter 1, Subchapter J of Title 21 of 
the Code of Federal Regulations. 
 
 
3.  Getting More Information 
 
You can get more information about our requirements for lasers from our electronic 
product radiation control web page at http://www.fda.gov/cdrh/radhealth/.  
If you have questions about this guidance, contact (cid:39)(cid:68)(cid:81)(cid:3)(cid:43)(cid:72)(cid:90)(cid:72)(cid:87)(cid:87), Office of Communication, 
Education, and Radiation Programs, Center for Devices and Radiological Health, 
(cid:20)(cid:19)(cid:28)(cid:19)(cid:22)(cid:3)(cid:49)(cid:72)(cid:90)(cid:3)(cid:43)(cid:68)(cid:80)(cid:83)(cid:86)(cid:75)(cid:76)(cid:85)(cid:72)(cid:3)(cid:36)(cid:89)(cid:72)(cid:81)(cid:88)(cid:72)(cid:15)(cid:3)(cid:54)(cid:76)(cid:79)(cid:89)(cid:72)(cid:85)(cid:3)(cid:54)(cid:83)(cid:85)(cid:76)(cid:81)(cid:74)(cid:15)(cid:3)(cid:48)(cid:39)(cid:3)(cid:21)(cid:19)(cid:28)(cid:28)(cid:22), Fax: ((cid:22)(cid:19)(cid:20)) (cid:27)(cid:23)(cid:26)-(cid:27)(cid:24)(cid:19)(cid:21), or e-mail 
daniel.hewett@fda.hhs.gov.  
 
 
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