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Notices to the Laser Industry
Entire Set of Laser Notices - Note About Accessibility
| NO. |
DATE | SUBJECT |
21 CFR CROSS REF. |
| (2) |
November 21, 1975 | Laser Energy Source | 1040.10 (b) (17) |
| (3) |
November 21, 1975 | Emission Indicators on Energy Source | 1040.10 (f) (5) (iii) |
| (4) |
November 21, 1975 | Protective Eyewear - Visibility of Emission Indicator | 1040.10 (f) (5) (iv) |
| (6) |
June 22, 1976 | Emission Indicators - Brightness | 1040.10 (f) (5) |
| (7) |
June 23, 1976 | Components and Repair | 1040.10 (a) |
| (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 |
| (10) |
August 31, 1976 | Emission Indicator - Visibility | 1040.10 (f) (5) |
| (11) |
September 7, 1976 | Remote Interlock Connectors | 1040.10 (f) (3) |
| (12) |
September 9, 1976 |
Interlock Design |
1040.10 (f) (2) |
| (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 | Certain Military Lasers Exempt From 21 CFR 1040.10 & .11 | 1002 |
| (16) |
March 2, 1977 | Warning Labels For Dye And Multiple Wavelength Lasers | 1040.10 (g) |
| (17) |
March 2, 1977 | Optional Interlocks - Labeling | 1040.10 (f) (2) & (g) |
| (21) |
November 11, 1977 | Emission Delay – Remote Interlock Connector |
1040.10 (f) (3) & (5) (ii) |
| (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) |
| (27) |
October 16, 1980 | Laser Diodes Used in Fiber Optics Communication Systems | 1010.2, 1010.3, 1040.10, 1040.11 |
| (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) |
| (36) |
August 23, 1985 | Low Power Laser Exemption | 1002.10, 1002.12 |
| (37) |
October 21, 1985 | Walk-In Workstations | 1040.10 (f) (1) & (2) |
| (38) |
May 22, 1987 | Importation for Investigation And Evaluation | 1005 |
| (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 |
| (41) |
August 9, 1988 | Low Power Laser Reporting Exemption | 1002.10, .12, .30 (b), .40, .41, .50 |
| (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) |
| (45) |
August 15, 1995 | Labeling of Laser Products | 1040.10 (g) |
| (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) |
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) |
Updated August 25, 2008 |
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