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For this “CLASS 3B LASER PRODUCT” eye protection is required
and the system has to be operated in an enclosed area where the
entrance should be posted with the provided laser warning sign.
Figure 5 LD-Series Treatment Head Laser Aperture Label
“LASER APERTURE”
This label shows the location of the aperture (LD-series Treatment
Head tip) through which the laser radiation is emitted. Please see
“Description of the Beam Delivery System”.
Figure 6 LD-Series Treatment Head Hazard Symbol
“YELLOW TRIANGLE”
This is a hazard label warning that the system emits hazardous
light. See “CLASS 3B LASER PRODUCT.”
This declaration is required by the U.S. Food and Drug
Administration (FDA) in accordance with the standard 21 CFR
1040 - Performance Standards for Light-Emitting Products.
“This product is in conformity with performance standards for
laser products under 21 CFR 1040, except with respect to those
characteristics authorized by Variance Number 98V0816/7
effective October 7, 1998.”
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