Skip to main content
          Skip to FDA Search
          Skip to in this section menu
          Skip to footer links


U.S. flagAn official website of the United States government

					Here’s how you know
          			Dot gov**The .gov means it’s official.**Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you're on a federal government site.
							      SSL**The site is secure.** The **https://** ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely. 
			U.S. Food and Drug Administration
				
        Search
            Menu
							
						Search FDA
									
									Submit search 
		Featured
							Contact FDA
	                FDA Guidance Documents
	                Recalls, Market Withdrawals and Safety Alerts
	                Press Announcements
	                Warning Letters
	                Advisory Committees
	                En Español

					Products
            Food
							Drugs
							Medical Devices
							Radiation-Emitting Products
							Vaccines, Blood, and Biologics
							Animal and Veterinary
							Cosmetics
							Tobacco ProductsTopics
            About FDA
							Combination Products
							Regulatory Information
							Safety
							Emergency Preparedness
							International Programs
							News and Events
							Training and Continuing Education
							Inspections and Compliance
							Science and ResearchInformation For
            Consumers
	            Patients
	            Industry
	            Health Professionals
	            Federal, State and Local Officials 
 In this section:

                Laser Products and Instruments

Laser Products and Instruments Home
          Radiation-Emitting Products
          Radiation-Emitting Products and Procedures
          Home, Business, and Entertainment Products
          Laser Products and Instruments
          Notices to the Laser IndustryLaser Products and Instruments Notices to the Laser Industry
  
  	
    Subscribe to Email Updates
    Share
    Post
    Linkedin

    Email
    PrintEntire Set of Laser Notices

NO.
			DATE
			SUBJECT
			21 CFR CROSS REF.(2)
			November 21, 1975
			Laser Energy Source
			1040.10 (b) (17)(8)
			August 5, 1976
			Viewing Optics - Sighting Telescope
			1040.10 (f) (8)(9)
			August 23, 1976
			Certain Military Lasers Exempt From 21 CFR 1040.10 & .11
			1002(11)
			September 7, 1976
			Remote Interlock Connectors
			1040.10 (f) (3)(13)
			October 14, 1976
			Laser Kits
			1040.10, 1010.2(14)
			November 23, 1976
			Lasers Manufactured and Used In-House
			1010.2(15)
			December 8, 1976
			See Laser Notice NOs. 9 and 52
			1002(16)
			March 2, 1977
			Warning Labels For Dye And Multiple Wavelength Lasers
			1040.10 (g)(22)
			November 23, 1977
			Laser Light Shows Subject to Laser Product Performance Standard
			1040.10(a) &
			1040.11(c)(25)
			September 14, 1978
			Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce
			1010.5(30)
			August 25, 1980
			Alternate Wording For Caution Statement
			1040.10 (h) (1) (iv)(31)
			May 18, 1981
			Investigational Medical Laser Significant Risk Device
			812.2 (b)(34)
			January 20, 1985
			Medical Laser Delivery System Interlocks
			1040.10 (f) (1), & (2)(35)
			February 5, 1985
			User Instruction Hazard Warnings
			1040.10 (f) (1) (iii)(37)
			October 21, 1985
			Walk-In Workstations
			1040.10 (f) (1) & (2)(39)
			June 24, 1987
			User Instructions – Multi Axis Workstations
			1040.10 (h)(40)
			October 29, 1987
			Class II and IIIA Laser Light Show Projectors and Shows
			1040.10 & .11(42)
			December 18, 1989
			Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products
			1040.10 (i)(43)
			June 7, 1993
			Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems
			1040.10 (f) (6) (ii),
			1040.10 (f) (5)(44)
			August 11, 1995
			User Instruction for Medical Products
			1040.10 (h) (1) (i)(46)
			Dec. 11, 1995
			All Holders of Approved Variances For Laser Light Shows and Displays
			1010.4, 1040.11(c)(47)
			June 6, 1996
			Effective Visual Control of Laser Projections
			1040.11(c)(48)
			Sept. 5, 1996
			Identification Labels for Certain Class I Laser Products
			1010.3 (a) (1)(49)
			Sept. 5, 1996
			Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products
			1040.10 (f) (5) (i),
			1040.10 (f) (5) (iv)(50)
			July 26, 2001
			Laser Products - Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22 (Final Guidance for Industry and FDA) TO BE WITHDRAWN DECEMBER 31, 2024
			1040.10 & 11(51)
			May 27, 2001
			Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors (Final Guidance for Industry and FDA)
			1040.11(c)(52)
			July 12, 2002
			Guidance on the Department of Defense Exemption from the FDA Performance Standard for Laser Products (Guidance for Industry and FDA)
			1010.5 & 1040.10(53)
			March 23, 2007
			Approval of Alternate Means of Labeling for Laser Products (Guidance for Industry and FDA Staff)
			1010 & 1040.10(g)(54)
			January 6, 2006
			Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Guidance for Industry and FDA Staff)
			1040.10(55)
			September 25, 2007
			Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Guidance for Industry and FDA Staff)
			1010.4(a)(2)(56)
			January 19, 2018
			Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.1
			1040.10, 1040.11(57)
			October 2, 2017
			Classification and Requirements for Laser Illuminated Projectors (LIPs)
			1010.4, 1040.11(c)(58)
			January 31, 2023
			Surveying, Leveling and Alignment (SLA) Laser Products
			1040.11(b)

                                                                                  Content current as of:
      09/22/2023Laser Products and Instruments
 Subscribe to Lasers
                        Sign up to receive email updates on Lasers.
    Enter your email address to subscribe:
 Footer Links
    FDA Archive
          About FDA
          Accessibility
      Visitor Information
          Website Policies / Privacy
          No FEAR Act
          Vulnerability Disclosure Policy
      FOIA
          HHS.gov
          USA.gov
    Contact FDA
      Follow FDA on Facebook
      Follow FDA on X
      Follow FDA on Instagram
      Follow FDA on LinkedIn
      View FDA videos on YouTube
      Subscribe to FDA RSS feeds
    FDA Homepage
    Contact Number
      1-888-INFO-FDA (1-888-463-6332) Back toTop