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  1. Laser Products and Instruments

Notices to the Laser Industry

Entire Set of Laser Notices

NO.DATESUBJECT21 CFR CROSS REF.
(2)November 21, 1975Laser Energy Source1040.10 (b) (17)
(8)August 5, 1976Viewing Optics - Sighting Telescope1040.10 (f) (8)
(9)August 23, 1976Certain Military Lasers Exempt From 21 CFR 1040.10 & .111002
(11)September 7, 1976Remote Interlock Connectors1040.10 (f) (3)
(13)October 14, 1976Laser Kits1040.10, 1010.2
(14)November 23, 1976Lasers Manufactured and Used In-House1010.2
(15)December 8, 1976See Laser Notice NOs. 9 and 521002
(16)March 2, 1977Warning Labels For Dye And Multiple Wavelength Lasers1040.10 (g)
(22)November 23, 1977Laser Light Shows Subject to Laser Product Performance Standard1040.10(a) &
1040.11(c)
(25)September 14, 1978Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce1010.5
(30)August 25, 1980Alternate Wording For Caution Statement1040.10 (h) (1) (iv)
(31)May 18, 1981Investigational Medical Laser Significant Risk Device812.2 (b)
(34)January 20, 1985Medical Laser Delivery System Interlocks1040.10 (f) (1), & (2)
(35)February 5, 1985User Instruction Hazard Warnings1040.10 (f) (1) (iii)
(37)October 21, 1985Walk-In Workstations1040.10 (f) (1) & (2)
(39)June 24, 1987User Instructions – Multi Axis Workstations1040.10 (h)
(40)October 29, 1987Class II and IIIA Laser Light Show Projectors and Shows1040.10 & .11
(42)December 18, 1989Clarification of Compliance Requirements for Certain Manufacturers Who Incorporate Certified Class I Laser Products into Their Products1040.10 (i)
(43)June 7, 1993Beam Attenuators and Emission Indicators for Class II and IIIa Laser Systems1040.10 (f) (6) (ii),
1040.10 (f) (5)
(44)August 11, 1995User Instruction for Medical Products1040.10 (h) (1) (i)
(46)Dec. 11, 1995All Holders of Approved Variances For Laser Light Shows and Displays1010.4, 1040.11(c)
(47)June 6, 1996Effective Visual Control of Laser Projections1040.11(c)
(48)Sept. 5, 1996Identification Labels for Certain Class I Laser Products1010.3 (a) (1)
(49)Sept. 5, 1996Emitted Laser Beam as Emission Indicator for Class II and Class IIIa Laser Products1040.10 (f) (5) (i),
1040.10 (f) (5) (iv)
(51)May 27, 2001Responsibilities of Laser Light Show Projector Manufacturers, Dealers, and Distributors (Final Guidance for Industry and FDA)1040.11(c)
(52)July 12, 2002Guidance 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, 2007Approval of Alternate Means of Labeling for Laser Products (Guidance for Industry and FDA Staff)1010 & 1040.10(g)
(54)January 6, 2006Exemption from Reporting and Recordkeeping Requirements for Low Power Laser Products (Guidance for Industry and FDA Staff)1040.10
(55)September 25, 2007Procedures for Renewal and Amendment of Certain Laser Light Show Variances (Guidance for Industry and FDA Staff)1010.4(a)(2)
(56)January 19, 2018Laser Products - Conformance with IEC 60825-1 Ed. 3 and IEC 60601-2-22 Ed. 3.11040.10, 1040.11
(57)October 2, 2017Classification and Requirements for Laser Illuminated Projectors (LIPs)1010.4, 1040.11(c)
(58)January 31, 2023Surveying, Leveling and Alignment (SLA) Laser Products1040.11(b)

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