§1040.10. Laser products. — Inbound Citations

(e) Laser products under § 1040.10 of this chapter that incorporate a certified laser system (laser product) will be considered to have met the certification requirements in this section if all of the following conditions are met:

(1) The incorporated laser system is not a laser product intended for use as a component or replacement as described in § 1040.10(a)(1) and (2) of this chapter;

(2) The manufacturer of the incorporated laser system has certified such laser system under this section and meets the reporting requirements under part 1002 of this chapter;

(3) The product incorporating the certified laser system is not independently subject to additional reporting or performance standards requirements;

(4) The incorporated laser system is not modified as defined in § 1040.10(i) of this chapter, and all performance features that apply to the incorporated laser system under § 1040.10(f) are available on the product incorporating the certified laser system;

(5) All labeling requirements that apply to the incorporated laser system under §§ 1010.2, 1010.3, 1040.10(g), and 1040.11(a)(3) of this chapter are visible on the outside of the product incorporating the certified laser system, with the exception that the certification or identification labels need not be visible on the outside of products incorporating a certified Class I laser;

(6) The incorporated laser system is installed in accordance with the instructions provided by the manufacturer of the incorporated laser system, including instructions for placing additional externally facing labels found in paragraph (e)(5) of this section, and meeting the other conditions in paragraphs (e)(1) through (8) of this section;

(7) The manufacturer of the product that incorporates the laser system provides the end user with information required under § 1040.10(h)(1) of this chapter as provided to them by the manufacturer of the incorporated laser system; and

(8) The labeling requirements under part 1010 and § 1040.10(g) of this chapter for the incorporated laser system would be met in any service configuration of the product incorporating the laser system or when the incorporated laser system is removed from the product into which it had been incorporated, and reproductions of such labels are found in the user information.

(a) Each medical laser product shall comply with all of the applicable requirements of § 1040.10 for laser products of its class. In addition, the manufacturer shall:

(1) Incorporate in each Class III or IV medical laser product a means for the measurement of the level of that laser radiation intended for irradiation of the human body. Such means may have an error in measurement of no more than 20 percent when calibrated in accordance with paragraph (a)(2) of this section. Indication of the measurement shall be in International System Units. The requirements of this paragraph do not apply to any laser radiation that is all of the following:

(i) Of a level less than the accessible limits of Class IIIa; and

(ii) Used for relative positioning of the human body; and

(2) Supply with each Class III or IV medical laser product instructions specifying a procedure and schedule for calibration of the measurement system required by paragraph (a)(1) of this section.

(3) Affix to each medical laser product, in close proximity to each aperture through which is emitted accessible laser radiation in excess of the accessible emission limits of Class I, a label bearing the wording: “Laser aperture.”

(1) The incorporated laser system is not a laser product intended for use as a component or replacement as described in § 1040.10(a)(1) and (2) of this chapter;

(1) The incorporated laser system is not a laser product intended for use as a component or replacement as described in § 1040.10(a)(1) and (2) of this chapter;

(4) The incorporated laser system is not modified as defined in § 1040.10(i) of this chapter, and all performance features that apply to the incorporated laser system under § 1040.10(f) are available on the product incorporating the certified laser system;

(5) All labeling requirements that apply to the incorporated laser system under §§ 1010.2, 1010.3, 1040.10(g), and 1040.11(a)(3) of this chapter are visible on the outside of the product incorporating the certified laser system, with the exception that the certification or identification labels need not be visible on the outside of products incorporating a certified Class I laser;

(7) The manufacturer of the product that incorporates the laser system provides the end user with information required under § 1040.10(h)(1) of this chapter as provided to them by the manufacturer of the incorporated laser system; and

(4) The incorporated laser system is not modified as defined in § 1040.10(i) of this chapter, and all performance features that apply to the incorporated laser system under § 1040.10(f) are available on the product incorporating the certified laser system;