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  1. Laser Products and Instruments

Notices to the Laser Industry

Entire 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Laser Products - Conformance with IEC 60825-1, Am. 2 and IEC 60601-2-22 (Final Guidance for Industry and FDA) TO BE WITHDRAWN DECEMBER 31, 2024 1040.10 & 11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)

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