NO. |
DATE |
SUBJECT |
21 CFR CROSS REF. |
(1) |
|
No Record of Laser Notice #1 |
|
(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) |
(5) |
January 26, 1976 |
Relationship of Integrated Radiance to Scanned Radiation, Response to 21 CFR 1040.10(d) and (e) - Considered Obsolete |
1040.10 (d) and (e) |
(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 |
Interlocks - Considered Obsolete |
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) |
(18) |
May 5, 1997 |
Aiming Beam on Medical Product |
|
(19) |
May 10, 1977 |
Electronic Product Import Procedures and Forms - Not included See FDA/CDRH Import requirements |
|
(20) |
July 1, 1977 |
Safety Interlocks to Prevent Access to Class II levels of Radiation - Considered Obsolete |
|
(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) |
| (23) |
February 21, 1978 |
Interim Enforcement Policy for Certain Light Shows and Displays - Considered Obsolete |
1040.10 & 1040.11 |
| (24) |
June 13, 1978 |
Modified Aperture Label for Products Used for Positioning and Alignment - Considered Obsolete |
1040.10(g) |
(25) |
September 14, 1978 |
Exemption of Certain Lasers Used By DOE, NOAA and U.S. Dept. of Commerce |
1010.5 |
(26) |
December 11, 1979 |
Enforcement Policy for Certain Laser Light Shows, Displays and/or Devices |
1040.10 & 1040.11 |
(27) |
October 16, 1980 |
Laser Diodes Used in Fiber Optics Communication Systems |
1010.2, 1010.3, 1040.10, 1040.11 |
(28) |
December 31, 1980 |
Approbal of Alternative Wording for Labels Involving Visible Radiation Only - Considered Obsolete |
|
(29) |
March 31, 1981 |
Clarification of Certain Light Show Requirements - Considered Obsolete |
|
(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) |
(32) |
August 29, 1983 |
Interlocks to Prevent Access to Certain Levels of Radiation Exceedng Class 1 - Considered Obsolete - Not Included |
|
(33) |
|
FDA/CDRH Index does not specify a record for Laser Notice #50. However the following document has been inserted in its place based on the issue date. |
|
???? |
January 19, 1984 |
Medical Laser Products Incorporating Visible Laser Aiming Beams |
|
(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) |
| ???? |
May 14, 1997 |
Date of Manufacture Label Requirement |
|
| ???? |
May 14, 1997 |
Importation of Radiation - Emitting Products for Investigation &Evaluation During Design Development |
|
(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) |