a Class II or IIIa laser product shall incorporate an emission indicator that provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I.

(ii) Each laser system classified as a Class IIIb or IV laser product shall incorporate an emission indicator which provides a visible or audible signal during emission of accessible laser radiation in excess of the accessible emission limits of Class I, and sufficiently prior to emission of such radiation to allow appropriate action to avoid exposure to the laser radiation.

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(iii) For laser systems manufactured on or before August 20, 1986, if the laser and laser energy source housed separately and can be operated at a separation distance of greater than 2 meters, both laser and laser energy source shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section. For laser systems manufactured after August 20, 1986, each separately housed laser and operation control of a laser system that regulates the laser or collateral radiation emitted by a product during operation shall incorporate an emission indicator as required in accordance with paragraph (f)(5) (i) or (ii) of this section, if the laser or operation control can be operated at a separation distance greater than 2 meters from any other separately housed portion of the laser product incorporating an emission indicator.

(iv) Any visible signal required by paragraph (f)(5) (i) or (ii) of this section shall be clearly visible through protective eyewear designed specifically for the wavelength(s) of the emitted laser radiation.

(v) Emission indicators required by paragraph (f)(5) (i) or (ii) of this section shall be located so that viewing does not require human exposure to laser or collateral radiation in excess of the accessible emission limits of Class I and Table VI.

(6) Beam attenuator. (i) Each laser system classified as a Class II, III, or IV laser product shall be provided with one or more permanently attached means, other than laser energy source switch(es), electrical supply

main connectors, or the key-actuated master control, capable of preventing access by any part of the human body to all laser and collateral radiation in excess of the accessible emission limits of Class I and Table VI.

(ii) If the configuration, design, or function of the laser product would make unnecessary compliance with the requirement in paragraph (f)(6)(i) of this section, the Director, Office of Compliance (HFZ-300), Center for Devices and Radiological Health, may, upon written application by the manufacturer, approve alternate means to accomplish the radiation protection provided by the beam attenuator.

(7) Location of controls. Each Class IIa, II, III, or IV laser product shall have operational and adjustment controls located so that human exposure to laser or collateral radiation in excess of the accessible emission limits of Class I and Table VI is unnecessary for operation or adjustment of such controls.

(8) Viewing optics. All viewing optics, viewports, and display screens incorporated into a laser product, regardless of its class, shall limit the levels of laser and collateral radiation accessible to the human eye by means of such viewing optics, viewports, or display screens during operation or maintenance to less than the accessible emission limits of Class I and Table VI. For any shutter or variable attenuator incorporated into such viewing optics, viewports, or display screens, a means shall be provided:

(i) To prevent access by the human eye to laser and collateral radiation in excess of the accessible emission limits of Class I and Table VI whenever the shutter is opened or the attenuator varied.

(ii) To preclude, upon failure of such means as required in paragraph (f)(8)(i) of this section, opening the shutter or varying the attenuator when access by the human eye is possible to laser or collateral radiation in excess of the accessible emission limits of Class I and Table VI.

(9) Scanning safeguard. Laser products that emit accessible scanned laser radiation shall not, as a result of any failure causing a change in either scan

velocity or amplitude, permit human access to laser radiation in excess of:

(i) The accessible emission limits of the class of the product, or

(ii) The accessible emission limits of the class of the scanned laser radiation if the product is Class IIIb or IV and the accessible emission limits of Class IIIa would be exceeded solely as result of such failure.

(10) Manual reset mechanism. Each laser system manufactured after August 20, 1986, and classified as a Class IV laser product shall be provided with a manual reset to enable resumption of laser radiation emission after interruption of emission caused by the use of a remote interlock or after an interruption of emission in excess of 5 seconds duration due to the unexpected loss of main electrical power.

(g) Labeling requirements. In addition to the requirements of §§ 1010.2 and 1010.3, each laser product shall be subject to the applicable labeling requirements of this paragraph.

(1) Class IIa and II designations and warnings. (i) Each Class IIa laser product shall have affixed a label bearing the following wording: "Class IIa Laser Product-Avoid Long-Term Viewing of Direct Laser Radiation."

(ii) Each Class II laser product shall have affixed a label bearing the warning logotype A (Figure 1 in this paragraph) and including the following wording:

[Position I on the logotype]

"LASER RADIATION-DO NOT STARE INTO BEAM"; and

[Position 3 on the logotype]

"CLASS II LASER PRODUCT".

"LASER RADIATION-AVOID DIRECT EXPOSURE TO BEAM"; and,

[Position 3 on the logotype]

"CLASS IIIb LASER PRODUCT". (3) Class IV designation and warning. Each Class IV laser product shall have affixed a label bearing the warning logotype B (Figure 2 of paragraph (g)(2)(ii) of this section), and including the following wording:

[Position 1 on the logotype]

"LASER RADIATION-AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION"; and,

[Position 3 on the logotype]

"CLASS IV LASER PRODUCT".

(4) Radiation output information on warning logotype. Each Class II, III, and IV laser product shall state in appropriate units, at position 2 on the required warning logotype, the maximum output of laser radiation, the pulse duration when appropriate, and the laser medium or emitted wavelength(s).

(5) Aperture label. Each laser product, except medical laser products and Class IIa laser products, shall have affixed, in close proximity to each aperture through which is emitted accessible laser or collateral radiation in

excess of the accessible emission limits of Class I and Table VI of paragraph (d) of this section, a label(s) bearing the following wording as applicable.

(i) "AVOID EXPOSURE-Laser radiation is emitted from this aperture," if the radiation emitted through such aperture is laser radiation.

(ii) "AVOID EXPOSURE-Hazardous electromagnetic radiation is emitted from this aperture," if the radiation emitted through such aperture is collateral radiation described in Table VI, item 1.

(iii) "AVOID EXPOSURE-Hazardous x-rays are emitted from this aperture," if the radiation emitted through such aperture is collateral radiation described in Table VI, item 2.

(6) Labels for noninterlocked protective housings. For each laser product, labels shall be provided for each portion of the protective housing which has no safety interlock and which is designed to be displaced or removed during operation, maintenance, or service, and thereby could permit human access to laser or collateral radiation in excess of the limits of Class I and Table VI. Such labels shall be visible on the protective housing prior to displacement or removal of such portion of the protective housing and visible on the product in close proximity to the opening created by removal or displacement of such portion of the protective housing, and shall include the wording:

(i) "CAUTION-Laser radiation when open. DO NOT STARE INTO BEAM." for Class II accessible laser radiation.

(ii) "CAUTION-Laser radiation when open. DO NOT STARE INTO BEAM OR VIEW DIRECTLY WITH OPTICAL INSTRUMENTS." for Class IIIa accessible laser radiation with an irradiance less than or equal to 2.5×10-3 W cm-2.

(iii) "DANGER-Laser radiation when open. AVOID DIRECT EYE EXPOSURE." for Class IIIa accessible laser radiation with an irradiance greater than 2.5 × 10-3 W cm-2.

(iv) "DANGER-Laser radiation when open. AVOID DIRECT EXPOSURE TO BEAM." for Class IIIb accessible laser radiation.

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(v) "DANGER-Laser when open. AVOID EYE OR SKIN EXPOSURE TO DIRECT OR SCATTERED RADIATION." for Class IV accessible laser radiation.

(vi) "CAUTION-Hazardous electromagnetic radiation when open." for collateral radiation in excess of the accessible emission limits in Table VI, item 1 of paragraph (d) of this section.

(vii) "CAUTION-Hazardous x-rays when open." for collateral radiation in excess of the accessible emission limits in Table VI, item 2 of paragraph (d) of this section.

(7) Labels for defeatably interlocked protective housings. For each laser product, labels shall be provided for each defeatably interlocked (as described in paragraph (f)(2)(iv) of this section) portion of the protective housing which is designed to be displaced or removed during operation, maintenance, or service, and which upon interlock defeat could permit human access to laser or collateral radiation in excess of the limits of Class I or Table VI. Such labels shall be visible on the product prior to and during interlock defeat and in close proximity to the opening created by the removal or displacement of such portion of the protective housing, and shall include the wording: