CDRH Laser Devices Class IIIa Power Test | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Complied FDA Performance Standards for Laser Products | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
The CDRH (Center for Devices and Radiological
Health)- 21CFR1040.10 procedure for measuring laser output is the energy
detectable through a circular aperture stop having a diameter of 7 mm
at a distance of 20 cm from the probe tip or laser diodes. Konftec's visible red laser diode (typical wavelength of 660nm laser diode) equipped in the Klas series is with the specification of beam divergence 9° (Parallel Angle) x 19° (Perpendicular Angle). Because of the divergence of the beam, the distance and the aperture used, the energy detectable falls within the Class IIIa (wavelength 400nm ~ 710nm visible laser with radiation power <5 mW) laser product standard. The typical average power for all 50mW and some 100mW laser devices shown on the warning logotype in our brochure and user's guide is <5 mW/cm² as measured in accordance with the procedure described above. |
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